Clinical trial NCT01509612
Conditions: Malignant Tumors
Keywords: cancer additive homeopathy patients with advanced malignant tumors
Sponsor: Medical University of Vienna
Start date: 2012-02-01; Completion date: 2019-07-31
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment.

The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.

Detailed description:
The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.

Arms: arm 1: Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules arm 2: Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules arm 3: No intervention
Interventions: intervention 1: Additive classical homeopathy intervention 2: Homeopathic Placebo globules
Intervention descriptions: intervention 1: Homeopathic remedies every 2 to 3 months intervention 2: Homeopathic placebo globules every 2 to 3 months

Protocol documents:
Prot_SAP_001.pdf: 
Prospective, randomized, placebo-controlled, double-
blind, three-arm multicenter study evaluating survival 
and quality of life in patients with non small-cell lung 
carcinoma with or without “add-on” homeopathy 
 
NCT01509612 
 
February 6, 2014  


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Homeopathy in cancer (HINC) 
Study protocol  
 
Prospective, randomized, placebo-controlled, double-blind, three-arm multicenter study 
evaluating survival and quality of life in patients with non small-cell lung carcinoma with or 
without “add-on” homeopathy  
 
 
Acronym: HINC 
PROJECT- OBJECTIVES & AIMS: 
We want to test for   
1. Survival time  
2. Quality of Life (QoL) 
3. Subjective well-being 
of conventionally treated cancer patients, with patients who receive an “add-on” homeopathic 
treatment and placebo homeopathic treatment in a double blind randomized prospective non 
interventional three-arm clinical trial. In addition, we want to investigate homeopathy as a 
system versus homeopathy as a medicine.  
PROPOSER  
Partner  
Contact 
Location 
Profession / Role 
Proposer 
Partner 1  
Michael Frass 
AKH KIM-1 
Project leader 


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1 
TABLE OF CONTENT 
1 
CONTENT AND ABSTRACT ............................................................................................ 3 
2 
BACKGROUND ................................................................................................................... 5 
2.1 
CANCER .......................................................................................................................... 5 
2.2 
POTENTIAL OF HOMEOPATHY IN CANCER PATIENTS ..................................................... 5 
3 
AIM HYPOTHESIS ............................................................................................................. 7 
4 
OVERALL TRIAL  DESCRIPTION ................................................................................. 7 
5 
METHODOLOGY ............................................................................................................... 8 
5.1 
CLINICAL TRIAL ............................................................................................................. 8 
5.2 
PARAMETER ANALYSIS ................................................................................................ 13 
6 
INTERDISCIPLINARY PROJECT TEAM MEMBERS .............................................. 14 
7 
PROJECT RESSOURCES ................................................................................................ 13 
7.1 
PARTNERSHIP ............................................................................................................... 14 
7.2 
RELATION TO OTHER PROJECTS ................................................................................... 15 
8 
POST PROJECT ACTIVITIES / RESULT EXPLOITATION..................................... 15 
9 
TIMETABLE OVERVIEW .............................................................................................. 15 
10 
WORK PLAN OVERVIEW.............................................................................................. 16 
11 
EFFECT ON IMPROVEMENT OF CLINICAL PRACTICE AND TREATMENT OF 
PATIENTS ................................................................................................................................... 16 
12 
STUDY RATIONALE ....................................................................................................... 16 
13 
ETHICAL ASPECTS OF THE PROJECT ..................................................................... 16 
14 
COMMON RULES AND REGULATIONS .................................................................... 16 
14.1 
NATIONAL COOPERATION ............................................................................................ 17 
14.2 
HUMAN RESOURCES .................................................................................................... 17 
15 
RESEARCH VENUE ......................................................................................................... 17 
 


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GERMAN ABSTRACT - PROJECT SUMMARY  
Prospektive, randomisierte, placebo-kontrollierte, doppel-blinde, dreiarmige multicenter 
Studie zur Evaluation des Überlebens und der Lebensqualität von PatientInnen mit 
nicht-kleinzelligem Lungenkarzinom mit oder ohne additive Homöopathie. 
 
Homöopathie wird kontroversiell diskutiert. Eine frühere Studie hat gezeigt, dass eine 
begleitende homöopathische Behandlung Lebensqualität und subjektives Befinden im Vergleich 
zu nicht homöopathisch behandelten PatientInnen positiv beeinflusst (Frass M et al. Additional 
treatment with homeopathy in cancer patients. Third European Congress for Integrative 
Medicine, Berlin 2010). Das Ziel dieser prospektiven randomisierten placebo-kontrollierten, 
doppelblinden, drei-armigen multizentrischen Studie ist es daher, bei PatientInnen mit nicht 
kleinzelligen Lungenkarzinomen (NSCLC) Stadium IV sowohl die Überlebenszeit als auch die 
Lebensqualität und subjektives Befinden von PatientInnen mit oder ohne homöopathische 
Begleittherapie zu untersuchen. Eine dritte Gruppe wird ohne jegliche homöopathische 
Intervention hinsichtlich des Überlebens beobachtet und dient als Kontrollgruppe. Damit wird 
die Homöopathie als System untersucht um jegliche psychosomatische Interaktion 
auszuschließen. Zudem wird die „Patients´ Voice“ durch eine integrierte sozialwissenschaftliche  
Erhebung erforscht. 
ENGLISH ABSTRACT 
Traditionally, homeopathy is discussed controversially. A previous study showed that “add”-on 
homeopathic treatment of tumor patients influences life quality and subjective well-being 
positively as compared to patients without add-on homeopathy (Frass M et al. Additional 
treatment with homeopathy in cancer patients. Third European Congress for Integrative 
Medicine, Berlin 2010). The aim of the present prospective randomized, placebo-controlled, 
open-label double-blind, three-armed multicenter study is to evaluate survival as well as quality 
of life (QoL) and subjective well-being in add-on homeopathically treated patients with non 
small-cell lung carcinoma (NSCLC) IV. A third group without any homeopathic intervention is 
observed regarding survival and serves as a second control group. Thereby, in our project 
homeopathy is also investigated as a system in order to rule out any psychosomatic 
intervention.  Furthermore, „patients´ voice“ will be investigated by an integral social scientific 
research. 
 


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2 
BACKGROUND 
2.1 
CANCER 
 
Non-small cell lung cancer (NSCLC) stage IV – Zöchbauer-Müller 
PREVALENCE – DIAGNOSIS – TREATMENT  
NSCLC comprises about 85% of all lung cancers. About 40% of patients with NSCLC are 
diagnosed with stage IV disease by image guided methods. These patients are treated with first-
line chemotherapy.  
First-line chemotherapy of advanced NSCLC consists of platinum-based doublets containing 
third generation anticancer drugs. Chemotherapy in addition to best supportive care improves 
survival with an absolute gain of approximately 10% at 1 year (NSCLC Collaborative Group JCO 
2008, 26, 4617). 
Median survival is about 10.1 months (Pirker R, et al; FLEX Study Team. Cetuximab plus 
chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label 
randomised phase III trial. Lancet 2009 2;373:1525-31) and 1-year survival rates are about 40%. 
2.2 
POTENTIAL OF HOMEOPATHY IN CANCER PATIENTS 
The underlying work hypothesis of classical homeopathy is to apply a remedy which simulates 
symptoms as close as possible as the symptoms a sick person. It is claimed that homeopathy 
strengthens the body by constitutional support. In cancer patients, additional features might be 
of interest, such as alleviating side effects of conventional chemotherapy, radiation as well as 
surgical therapy; ameliorating secondary diseases; and improving life quality.  
In principle, the additive homeopathic treatment of cancer patients is not different from 
treatment of patients suffering from various other diseases. 
A recent study describes the process and outcome of a selected case series review through the 
NCI BCS Program. The results of the review were deemed to be sufficient to warrant NCI 
initiated prospective research follow-up in the form of an observational study (Banerji P, 
Campbell D, Banerji P. Cancer patients treated with the Banerji protocols utilizing homoeopathic 
medicine: A Best Case Series Program of the National Cancer Institute. USA Oncology Reports 
20: 69-74, 2008). Two patients with lung carcinoma showed complete remission without 
conventional therapy.  


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Dario Spinedi and Jens Wurster have published a book describing the use of homeopathy in 
severe cancer cases (Jens Wurster: Homeopathic treatment and cure of cancer and 
metastasized carcinoma, Peter Irl Verlag, 2010).  
A previous study suggests a possible positive effect of “add-on” homeopathic treatment with 
regard to life quality and subjective well-being in patients suffering from various tumor entities 
and stages (Frass M et al. Additional treatment with homeopathy in cancer patients. Third 
European Congress for Integrative Medicine, Berlin 2010). Three questionnaires, the EORTC 
QLQ-C30, the SF-36, as well as a specific new validated questionnaire were completed by the 
patients at the first appointment as well as at each follow-up. The questionnaires had to be 
completed at least three times to evaluate a possible influence of homeopathic medication. A 
colleague mentioned that she has the impression that cancer patients treated additively with 
homeopathy live longer. Therefore, we performed a thesis evaluating survival. To our surprise, 
patients lived much longer than expected: 
 
 


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The aim of the proposed study is to evaluate whether survival as well as life quality and 
subjective well-being might be influenced by homeopathy in patients suffering from non-small 
cell lung carcinoma (NSCLC) stage IV.  
3 
AIM HYPOTHESIS 
We aim to investigate the validity of our previous results (Frass M et al. Additional treatment 
with homeopathy in cancer patients. Third European Congress for Integrative Medicine, Berlin 
2010)  in a randomized prospective, placebo-controlled, double-blind, three-arm multicenter 
controlled evaluation of survival as well as of QoL by questionnaires in patients with advanced 
NSCLC. We plan to compare the treatment outcome (survival and QoL) in tumor patients, 
receiving verum or placebo homeopathic treatment. A third group without any homeopathic 
intervention is observed regarding survival and serves as non-interventional control group. 
Thereby, homeopathy is also investigated as a system to rule out any psychosomatic 
interaction. 
 
The null hypothesis is that “add-on” homeopathic treatment does not create a benefit with 
regard to survival for NSCLC patients. In addition we evaluate Quality of Life (QoL). 
4 
OVERALL TRIAL DESCRIPTION  
In a collaboration with (see names of the interdisciplinary project team members under item 
“6” of this document) 
1. ) specialists for conventional tumor treatment and  
2.) trained homeopaths, we want to explore the possible effects of “add-on”   
      homeopathic treatment in cancer patients.   
 we will perform a prospective, randomized, placebo-controlled, double-blind, 
multicenter evaluation of questionnaires to compare the three arms (with placebo and 
with verum add-on homeopathic treatment; patients with standard care without any 
homeopathic intervention) 
 The study parameters will be 1) patient survival, 2) quality of life and subjective well-
being from time of diagnosis, 3) patients´ voice. 
 Considering the patient frequency at the proposer’s site we foresee project duration of 
about seven years: 300 patients will be recruited. An interim analysis with non-binding 
stopping for futility option will be performed after the observation of 140 events. 


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5 
METHODOLOGY 
5.1 
CLINICAL TRIAL 
5.1.1 
Patient recruitment   
The newly diagnosed patients are recruited at the participating centers. Inclusion criteria are: 
Patients older than 18 years suffering from NSCLC stage IV or IIIB, IIIC diagnosed within the last 
8 weeks. Exclusion criteria are: Patients not willing to sign informed consent and pregnant 
patients; sensitizing mutation of the EGFR gene or translocation of the ALK gene; hematological, 
hepatic or renal pathology; coronary heart disease; history of secondary tumor; major surgery 
within 4 weeks prior to study entry; active infection, and symptomatic peripheral neuropathy 
(National Cancer Institute’s common toxicity criteria, version 2, grade ≥2); central nervous 
system metastases unless the metastases were treated and stable; active autoimmune disease; 
use of systemic immunosuppressive treatment; use of systemic treatment during the previous 2 
years; active interstitial lung disease, or a history of pneumonitis for which glucocorticoids were 
prescribed; previous systemic therapy for metastatic disease or previous irradiation; use of any 
complementary and/or alternative therapy, including homeopathy other than the research 
treatment, during the trial. Following agreement to participate and signature on the informed 
consent form, the patient completes the three questionnaires as described below. Then, a 
classical homeopathic anamnesis is taken by the homeopathic physician. Following the 
anamnesis, a homeopathic repertorisation is performed. Finally, the physician explains the 
patient how to take the prescribed remedies without giving the names of the remedies to them. 
Then, the physician prescribes the remedies and telefaxes the prescription on a special form, or 
emails them to the pharmacy. At the pharmacy, the following stratification criteria are entered 
into a randomization program (Randomizer© Medical University Graz, Austria) for permuted 
blocks randomization: age of patient, sex, Karnofsky index, and center. The pharmacy now 
prepares the respective remedies and sends them blinded directly to the patient. This design 
insures the double–blind nature of the study as it creates a system where the treating physician 
is in no position to know which patient receives the verum or the placebo homeopathic 
medicine. 
Patients declining to participate undergo standard care alone without homeopathic 
intervention/treatment (verum or placebo). This group serves as control group without 
homeopathy as a third arm of the study.  This third arm is necessary to answer the question 
about the difference between medication and the homeopathic intervention itself (Brien S, 
Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has clinical benefits in rheumatoid 
arthritis patients that are attributable to the consultation process but not the homeopathic 


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remedy: a randomized controlled clinical trial. Rheumatology (Oxford). 2011;50:1070-82). 
Otherwise, one could hypothesize that the act of homeopathic intervention itself might have a 
significant effect which could be valuable to these terminal patients, yet our study design rules 
out such a scenario. For these non-participating patients, only survival time will be recorded, 
however, no questionnaires are completed. 
We assume that the number of patients who refuse to be randomized but chose to undergo 
homeopathy is very low. Therefore, this arm is not considered any further in this study. 
 
 
 
 
Sample size calculation is based on a significance level of 5% and a median survival of 10.1 
months for group 1 (without homeopathic add-on), see Pirker (Lancet, 2009). Furthermore, 60 
months recruitment period with a 24 months observational period in each patient is planned. 
Under these assumptions 300 patients (corresponding to an average accrual rate of 5 patients 
per month) give 85% power to detect a difference of 10.1 vs. 14.5 months. 
Since the trial duration is quite long a two-stage design (O’Brien-Fleming type with equal 
information rates) with an interim analysis is planned using the above assumptions: An interim 


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Analysis with non-binding stopping for futility option will be performed after the observation of 
140 events (which is expected to be after 22 months under the above assumptions). Early 
rejection of the null hypothesis at interim is tested at a two-sided significance level of 0.0052, 
the null hypothesis is accepted at interim (stopping for futility) if the p-value exceeds 0.5. The 
two-sided significance level for the second stage is 0.048. Maximum sample size is estimated to 
be 302 (corresponding to 279 events), expected (average) number of events is 209 under the 
null hypothesis and 242 under the alternative. 
 
5.1.2 
Questionnaires 
For the documentation of the quality of life, the QLQ-C30, the SF-36 and a subjective well-being 
questionnaire will be used at any visit. 
5.1.3 
Evaluation of patients’ survival 
Overall survival is the most objective end-point to be used in a clinical cancer study. Patients’ 
survival is recorded during control visits every 2 to 3 months. In addition, patients agree that 
one or two persons named by him/her may be contacted for study-specific follow-up 
clarification of the end-points. 
5.1.4 
Bringing in the patients´ voices 
In order to investigate the impact of homeopathy on the quality of life and particularly to better 
understand the patients’ health-seeking behavior and their experiences with complementary 
and alternative medicine (CAM) a qualitative social scientific study will be integral part of HINC. 
We seek to systematically research the ethical, legal, socio-political, and science theoretical 
dimensions of homeopathy as in the case of lung cancer (non small-cell lung carcinoma) 
exemplified. To our knowledge, there do not exist any qualitative studies at this point (Franzel, 
Schwiegershausen, Heusser, & Berger, 2013; Smithson, Paterson, Britten, Evans, & Lewith, 
2010). As such our integrated social scientific study would constitute the first qualitative study 
concerning the attitudes towards and experiences with homeopathy with respect to the 
treatment of cancer in Austria. 
In our integral social scientific study we follow suit the HINC study by conducting a systematic 
literature review and by operating expert interviews with a variety of individuals, such as 
researchers, medical experts, physicians, policy makers and homeopaths (including the project 
members). In the tradition of the “participatory turn” (Hajer & Wagenaar, 2003; Jasanoff, 2003) 
in the social sciences we understand patients as experts of their own. In order to reach out for 
them we prepare questionnaires investigating the reasons for their participation or non-


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participation in an additive homeopathic study like HINC. Those questionnaires with 
closed/open questions will be distributed together with the study design and the informed 
consent form and will produce our first empirical data. Additionally we will ask the patients to 
voluntarily participate in semi-structured qualitative interviews in order to further investigate 
their different perceptions of and attitudes towards homeopathy as a whole system. Finally we 
will conduct focus groups with those patients with terminal malignancies that actually take part 
in the HINC study, including their carers and relatives. Ideally we will organize focus groups 
(consisting of 4-10 participants) after the 3rd or 4th homeopathic treatment bringing together 
trial participants and their relatives, friends and carers (recruiting will be performed within the 
ordinary recruitment process). Our focus groups design allows us to study in-depth the 
interactions between individuals, collectively shared and uncontested assumptions, and the 
emergence of collective meaning (Hennink, 2007; Kitzinger, 1994; Krueger, 2009; Lezaun, 2007; 
Smithson, 2000). We plan to conduct 5-10 focus groups at each location, which also will enable 
us to explore similarities and differences between societal groups and different locations in 
Austria.  
Throughout the seven-year period of the proposed project, we plan to operate a circular 
approach of data collection and analysis (Glaser & Strauss, 1967). This mixed-methods approach 
will increase the validity of our findings and let us approach the phenomena of interest from 
various perspectives. For reasons of comparability and because of the large data sets, inductive 
coding and structured content analysis will be applied for analyzing the transcribed data 
(Krippendorff, 2004; Mayring, 2008). We will conduct the actual data analysis by using the 
computer software Atlas.ti. In a following step, we will explore the generated data in-depth 
drawing on interpretive approaches (Clarke, 2005; Fischer & Gottweis, 2012; Yanow, 2000). 
Nesting a qualitative study among the patients, their relatives and carers would be particularly 
valuable in trying to understand the impact that homeopathy has as a whole system on these 
patients with terminal malignancies. Finally we aim at increasing the project’s overall 
deliberative character (Schicktanz, 2009) and we will analyze the broader social and political 
dimensions of homeopathy as medical practice. 
 
Bibliography 
Clarke, A. (2005). Situational analysis: Grounded theory after the postmodern turn. Sage 
Publications, Inc. 
Fischer, F., & Gottweis, H. (Eds.). (2012). The Argumentative Turn Revisited: Public Policy as 
Communicative Practice. 


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Franzel, B., Schwiegershausen, M., Heusser, P., & Berger, B. (2013). Individualised medicine 
from the perspectives of patients using complementary therapies: a meta-ethnography 
approach. BMC Complementary and Alternative Medicine, 13(1), 1–1. doi:10.1186/1472-6882-
13-124 
Glaser, B. G., & Strauss, A. L. (1967). The discovery of grounded theory: Strategies for qualitative 
research. New Brunswick/London: AldineTransaction. 
Hajer, M. A., & Wagenaar, H. (2003). Introduction. In Deliberative Policy Analysis. 
Understanding Governance in the Network Society (pp. 1–30). Cambridge: Cambridge University 
Press. 
Hennink, M. M. (2007). International focus group research. 
Jasanoff, S. (2003). Technologies of Humility: Citizen Participation in Governing Science. 
Minerva, 41(3), 223–244. doi:10.1023/A:1025557512320 
Kitzinger, J. (1994). The methodology of Focus Groups: the importance of interaction between 
research participants. Sociology of Health & Illness, 16(1), 103–121. doi:10.1111/1467-
9566.ep11347023 
Krippendorff, K. (2004). Content Analysis. SAGE. 
Krueger, R. A. (2009). [CITATION][C]. 
Lezaun, J. (2007). A market of opinions: the political epistemology of focus groups. The 
Sociological Review, 55(Supplement s2), 130–151. doi:10.1111/j.1467-954X.2007.00733.x 
Mayring, P. (2008). Qualitative Inhaltsanalyse. Beltz. 
Schicktanz, S. (2009). The relevance of affected persons, the public, and deliberation for the 
empirical turn in medical ethics. Ethik in Der Medizin, 21(3), 223–234. doi:10.1007/s00481-009-
0020-0 
Smithson, J. (2000). Using and analysing focus groups: limitations and possibilities. International 
Journal of Social Research Methodology, 3(2), 103–119. doi:10.1080/136455700405172 
Smithson, J., Paterson, C., Britten, N., Evans, M., & Lewith, G. (2010). Cancer patients' 
experiences of using complementary therapies: polarization and integration. Journal of Health 
Services Research & Policy, 15(suppl 2), 54–61. doi:10.1258/jhsrp.2009.009104 
Yanow, D. (2000). Conducting Interpretive Policy Analysis. Sage University Paper series on 
Qualitative Research Methods Series (Vol. 47). Thousands Oaks, CA: Sage. 
 


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5.2 
PARAMETER ANALYSIS 
The obtained and recorded raw data from this prospective, randomized, placebo-controlled, 
double-blind, multicenter 3 arms trial will be used to compare between the two randomized 
groups with regard to the following outcomes: 
 primary outcome at 9 and 18 weeks versus base line:  
o QoL evaluated as Global Health Status 
o EORTC-QLQ-C30 (remaining dimensions) 
o SF-36 
o subjective well-being 
 secondary outcome: overall survival time after 2 years observation from diagnosis 
 side effects 
 patients´ voice 
 If study support enables a study nurse, analysis of antiemetic medication will be 
included  
 The non-randomized group without any add-on will be compared to each of the 
randomized groups with respect to overall survival (no other outcomes are measured 
for these patients). 
5.2.1 
Statistics 
 Multiple Imputation of missing QoL outcomes using the joint modeling approach by 
Rizopoulos (Rizopoulos, D. JM: An R package for the joint modelling of longitudinal and 
time-to-event data. J Statistical Software 2010; 35: 1–33.).  
 Kaplan-Meier curves will be used to graphically display the survival comparison between 
the groups. 
 Multi-variable Cox proportional hazards regression models will be used to compare the 
groups with respect to the survival outcome while controlling for the stratification 
criteria. 
 ANCOVA (Analysis of Co-Variance) models will be used for the evaluation of Global 
Health Status and further dimensions of EORTC-QLQ-C30 and SF-36. 
 Statistical analysis is done by intention-to-treat (ITT) since the use of homeopathy may 
be highly dependent on the compliance of the patients.  
 alpha=0.05 (two-sided), the significance levels for the two stages (interim, final stage) 
are given above (see 5.1.2). No further correction for multiple testing is done among the 
secondary and further outcome. 
 


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6 
INTERDISCIPLINARY PROJECT TEAM MEMBERS 
 
7 
PROJECT RESSOURCES  
7.1 
PARTNERSHIP 
The project benefits from the synergies of five specialized teams, which are coordinated by the 
project leader. The realization of the work packages is within the scope of each participating 
Partner 
Person 
Initials 
Role 
KIM-1 
Michael Frass, MD 
MF 
Internal physician, Homeopath 
KIM-1 
Sabine Zöchbauer-Müller, 
MD 
SZM 
Oncologist, NSCLC 
Otto-Wagner-
Hospital Vienna 
Otto Burghuber, MD  
OB 
Pulmonologist-Oncologist 
Maria Treu 
Pharmacy 
Ilse Muchitsch, PhD pharm  
IM 
Preparation of study 
substances, handling of placebo 
and verum 
Dept Internal 
Medicine Hospital 
Lienz  
Peter Lechleitner, MD 
PL 
Oncologist Homeopath 
Dept Medicine 
Elisabethinenspital, 
Linz 
Michael Schumacher, MD 
MS 
Oncologist 
Center for Medical 
Statistics, 
Informatics, and 
Intelligent Systems 
Andreas Gleiß, PhD 
AG 
Biostatistician 
Department of 
Political Science/ 
University of 
Vienna 
Paul Just, MA 
PJ 
Political Scientist 


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partner. The equipment and facilities are available at the partner’s institution. We request only 
the required additional man-power and project specific consumables for the study specific 
documentation work.  
As each team is well experienced and equipped for the planned work, no particular investments 
in hardware or training of personnel is necessary.  
7.2 
RELATION TO OTHER PROJECTS  
 The project largely benefits from work done previously.  
 Each partners’ project role is within the key competence of the according partner.  
8 
POST PROJECT ACTIVITIES / RESULT EXPLOITATION  
We envision various ways of data exploitation  
Publish the results in: 
 National and international meetings and  
 Peer reviewed journals 
 Web publications   
 Participation on “science days” to reach the interested public 
9 
TIMETABLE OVERVIEW 
1st year 
2nd year 
3rd year 
4th year 
5th year 
6th year 
7rth year 
Recruiting 
+ treating 
patients 
Recruiting 
+ treating 
patients 
Recruiting 
+ treating 
patients 
Recruiting 
+ treating 
patients 
Recruiting 
+ treating 
patients 
Treating 
patients 
Treating 
patients 
Statistical 
evaluation 
 


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10 WORK PLAN OVERVIEW 
Preparatory work [informed consent sheets; case report form (CRF)]: March to April 2012  
Distribution and collection of questionnaires: May 2012 – April 2018 
Statistical evaluation: May 2019 
11 EFFECT ON IMPROVEMENT OF CLINICAL PRACTICE AND TREATMENT OF 
PATIENTS 
If the outcome of the study reveals an improvement of survival, QoL, and subjective well-being 
it will have a severe impact on the future clinical practice for cancer patients in a way as 
homeopathy is a low-cost treatment and debits the public social security system to a minor 
degree. 
In addition the acceptance of homeopathy in a clinical environment increases the trust and 
confidence of those therapists, who consider the additive treatment as a valuable asset in their 
own specialized branch. 
Further on, a positive result of the study might invite potential investors and companies to 
support future research projects. 
12 STUDY RATIONALE  
Improvement of survival, quality of life, and subjective well-being is the major endpoint of the 
trial. 
13 ETHICAL ASPECTS OF THE PROJECT 
The advantage of potentiated homeopathic remedies is that the dosage does not affect the 
metabolism of the patient and does not cause interaction with conventional treatment of the 
involved cancer patients.  
14 COMMON RULES AND REGULATIONS 
The study is conducted according to GCP regulations installed at the Medical University of 
Vienna.  The study follows the Declaration of Helsinki. 


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14.1 NATIONAL AND INTERNATIONAL COOPERATION 
This project is a nationally coordinated and financially approved study within Austria and 
Germany under the involvement of the general Hospital of Vienna in close cooperation with the 
other clinics.  
14.2 HUMAN RESOURCES 
In total thirteen doctors and scientific staff members are involved. 
15 RESEARCH VENUE 
Research is performed at the  
 General Hospital of Vienna;  
 Otto Wagner Hospital, Vienna; 
 the Hospital of Lienz (Tirol); and  
 Elisabethinenspital, Department of Medicine, Linz, Austria 
The personnel involved works in the outpatient units of the respective hospitals.