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
  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: Homeopathic 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 Lung 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 quality 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: 150
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
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
No intervention

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
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:
Study First Received: January 7, 2012
Last Updated: July 27, 2016
Health Authority: Austria: Agency for Health and Food Safety
Individual Participant Data  
Plan to Share IPD: No

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 August 28, 2016