Additive Homeopathy in Cancer Patients (HIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Michael Frass, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01509612
First received: January 7, 2012
Last updated: July 27, 2016
Last verified: July 2016

January 7, 2012
July 27, 2016
January 2011
January 2018   (final data collection date for primary outcome measure)
Life quality [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Life quality is evaluated by using the results of the EORTC-QLQ-C30 questionnaire
Life quality [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01509612 on ClinicalTrials.gov Archive Site
Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Survival is evaluated by assessing time in months from diagnosis until death
Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Additive Homeopathy in Cancer Patients
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

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.

The EORTC-QLQ-C30 as well as a VAS scale for subjective well-being will be filled out by the patients.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Malignant Tumors
  • Drug: Additive classical homeopathy
    Homeopathic remedies every 2 to 3 months
    Other Name: Classical homeopathic remedies
  • Drug: Homeopathic Placebo globules
    Homeopathic placebo globules every 2 to 3 months
    Other Name: Homeopathic Placebo globules looking identical to verum
  • Active Comparator: Additive homeopathy in cancer patients
    Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules
    Intervention: Drug: Additive classical homeopathy
  • Placebo Comparator: Additive homeopathic placebo globules
    Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules
    Intervention: Drug: Homeopathic Placebo globules
  • No Intervention: No intervention
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2019
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Michael Frass, Prof. Dr. +43 1 40400 ext 4506 michael.frass@meduniwien.ac.at
Austria
 
NCT01509612
5
No
No
Not Provided
Michael Frass, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Frass, Prof. Dr. Medical University Vienna
Medical University of Vienna
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP