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
  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 April 16, 2014