Additive Homeopathy in Cancer Patients

Phase 3

Completed

• Conditions: Malignant Tumors
• Interventions: Drug: Homeopathic Placebo globules; Drug: Additive classical homeopathy

• Registration Number: NCT01509612
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-01-07
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Study Start: 2012-02-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Results First Submitted: 2020-02-23
• Results First Submitted QC: 2020-10-29
• Results First Posted: 2020-11-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additive homeopathic placebo globules	Homeopathic Placebo globules	Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules
Additive homeopathy in cancer patients	Additive classical homeopathy	Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Primary Outcome Measures

Name	Time	Method
EORTC-QLQ-C30 Score	baseline and at 18 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Survival	2 years for the individual patient (=whole study duration)	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

Trial Locations

Locations (1)

Michael Frass; 🇦🇹 Wien, Austria