Additive Homeopathy in Cancer Patients

Study Overview
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Brief Summary
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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
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The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.

Official Title
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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

Conditions
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Malignant Tumors

Intervention / Treatment
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* Drug: Additive classical homeopathy
* Drug: Homeopathic Placebo globules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Additive homeopathy in cancer patients<br>Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules | Drug: Additive classical homeopathy<br>* Homeopathic remedies every 2 to 3 months<br>* Other names: Classical homeopathic remedies;|
| Placebo Comparator: Additive homeopathic placebo globules<br>Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules | Drug: Homeopathic Placebo globules<br>* Homeopathic placebo globules every 2 to 3 months<br>* Other names: Homeopathic Placebo globules looking identical to verum;|
| No Intervention: No intervention<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC-QLQ-C30 Score | Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study. The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. | baseline and at 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival was assessed by chart review, at every study visit (every 9 weeks throughout the trial), and by information of the central mortality registry of Austria | 2 years for the individual patient (=whole study duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, additive homeopathy, patients with advanced malignant tumors