Additive Homeopathy in Cancer Patients (HIC)
This study is currently recruiting participants.
Verified July 2012 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Michael Frass, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01509612
First received: January 7, 2012
Last updated: July 11, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Malignant Tumors |
Drug: Additive classical homeopathy Drug: Placebo homeopathic globules Drug: Placebo globules |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Tumors With or Without "add-on" Homeopathy |
Resource links provided by NLM:
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- Life quality [ Time Frame: 7 years ] [ Designated as safety issue: No ]Life quaity is evaluated by using the results of the EORTC-QLQ-C30 questionnaire
Secondary Outcome Measures:
- Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]Survival is evaluated by assessing time in months from diagnosis until death
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Additive homeopathy in cancer patients |
Drug: Additive classical homeopathy
Homeopathic remedies every 2 to 3 months
Other Name: Classical homeopathic remedies
|
|
Placebo Comparator: Additive hom in cancer patients placebo
Patients of placebo group receive placebo homeopathic therapy
|
Drug: Placebo homeopathic globules
Homeopathic placebo globules every 2 to 3 months
Other Name: Placebo homeopathic globules looking identical to verum
Drug: Placebo globules
saccharose globules and dilutions taken orally
Other Name: Individually prepared homeopathic remedies
|
Detailed Description:
The EORTC-QLQ-C30 as well as a VAS scale for subjective well-being will be filled out by the patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent
- Clinical diagnosis of advanced tumor stages of glioblastoma IV, metastasized sarcoma, as well as non small-cell lung carcinoma (NSCLC) IV.
Exclusion Criteria:
- Pregnant patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509612
Contacts
| Contact: Michael Frass, Prof. Dr. | +43 1 40400 ext 4506 | michael.frass@meduniwien.ac.at |
| Contact: Cornelia Sax, MSc | +43 1 40400 ext 4421 | cornelia.sax@meduniwien.ac.at |
Locations
| Austria | |
| Medical University Vienna | Recruiting |
| Vienna, Austria, A 1090 | |
| Contact: Michael Frass, Prof. Dr. +43 1 40400 ext 4506 michael.frass@meduniwien.ac.at | |
| Principal Investigator: Michael Frass, Prof. Dr. | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| Principal Investigator: | Michael Frass, Prof. Dr. | Medical University Vienna |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael Frass, Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01509612 History of Changes |
| Other Study ID Numbers: | 5 |
| Study First Received: | January 7, 2012 |
| Last Updated: | July 11, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
cancer additive homeopathy patients with advanced malignant tumors |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013