Clinical trial NCT01509612: Additive Homeopathy in Cancer Patients
Official title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Study Evaluating Quality of Life in Patients With Advanced Malignant Lung Tumors With or Without "add-on" Homeopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Tumors
Keywords: cancer
additive homeopathy
patients with advanced malignant tumors
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.

Exclusion Criteria:

* sensitizing mutation of the EGFR gene or translocation of the ALK gene
* refusal to sign informed consent
* pregnancy
* 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
* 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

Primary outcomes:
measure: EORTC-QLQ-C30 Score
timeFrame: baseline and at 18 weeks
Secondary outcomes:
measure: Survival
timeFrame: 2 years for the individual patient (=whole study duration)
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Michael Frass
Study officials:
affiliation: Medical University Vienna
name: Michael Frass, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frass M, Lechleitner P, Grundling C, Pirker C, Grasmuk-Siegl E, Domayer J, Hochmair M, Gaertner K, Duscheck C, Muchitsch I, Marosi C, Schumacher M, Zochbauer-Muller S, Manchanda RK, Schrott A, Burghuber O. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. Oncologist. 2020 Dec;25(12):e1930-e1955. doi: 10.1002/onco.13548. Epub 2020 Nov 7.