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Additive Homeopathy in Cancer Patients (HIC)

This study is currently recruiting participants.
Verified July 2012 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 11, 2012
Last verified: July 2012
History of Changes

January 7, 2012
July 11, 2012
January 2011
January 2018   (final data collection date for primary outcome measure)
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
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 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: 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
  • Active Comparator: Additive homeopathy in cancer patients
    Intervention: Drug: Additive classical homeopathy
  • Placebo Comparator: Additive hom in cancer patients placebo
    Patients of placebo group receive placebo homeopathic therapy
    Interventions:
    • Drug: Placebo homeopathic globules
    • Drug: Placebo globules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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
No
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
Austria
 
NCT01509612
5
No
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 2012

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