Additive Homeopathy in Cancer Patients (HIC)
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|ClinicalTrials.gov Identifier: NCT01509612|
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : November 3, 2020
Last Update Posted : June 16, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Tumors||Drug: Additive classical homeopathy Drug: Homeopathic Placebo globules||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||February 1, 2012|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Active Comparator: Additive homeopathy in cancer patients
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules
Drug: Additive classical homeopathy
Homeopathic remedies every 2 to 3 months
Other Name: Classical homeopathic remedies
Placebo Comparator: Additive homeopathic placebo globules
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules
Drug: Homeopathic Placebo globules
Homeopathic placebo globules every 2 to 3 months
Other Name: Homeopathic Placebo globules looking identical to verum
No Intervention: No intervention
- EORTC-QLQ-C30 Score [ Time Frame: 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.
- Survival [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509612
|Wien, Austria, 1120|
|Principal Investigator:||Michael Frass, Prof. Dr.||Medical University Vienna|