Phase 3
Completed N=150
Additive Homeopathy in Cancer Patients
Source: ClinicalTrials.gov NCT01509612 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: EORTC-QLQ-C30 Score — 51.2; 46.6 score on a scale — p=0.397
◆ Published Evidence
Established
62citations · ~10 / year
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.
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EORTC-QLQ-C30 Score |
51.2; 46.6 | 0.397 |
| SECONDARY Survival |
23; 11; 7 | 0.02 sig |
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
Data sourced from ClinicalTrials.gov (NCT01509612) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.