Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Frass, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00861432
First received: March 12, 2009
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

Tumor patients receiving conventional tumor therapies are included into this study. The patients are randomized into two groups receiving either additive homeopathic therapy or not. Two questionnaires referring to subjective feeling and life quality are filled out by the patients with each visit to the outpatients Department. One of them is the QLQC30 questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.


Condition Intervention Phase
Tumor
Other: additive homeopathic treatment
Other: No additive homeopathic treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Difference with regard to subjective feeling and life quality with or without homeopathic treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: additive homeopathic treatment Other: additive homeopathic treatment
These patients receive homeopathic treatment
Other Name: homeopathic remedies according to the Pharmacopoeia
No Intervention: no additive homeopathic treatment
These patients do not receive homeopathic treatment
Other: No additive homeopathic treatment
These patients do not receive homeopathic treatment
Other Name: Patients receive no add-on hoemopathic tretament.

Detailed Description:

Quality of life is an important issue for cancer patients, especially during the periods of chemotherapy and radiation. Preliminary results have revealed positive effects of add-on homeopathy on quality of life as well as subjective well-being. Patients are receiving classical homeopathy with administration of either globules and/or dilutions. With each appointment, patients complete two questionnaires.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Tumor patients between 18 and 100 years old

Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.

  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: NCT00861432

Locations
Austria
Med. Univ. Vienna, Dept. Internal Med. I
Vienna, Austria, A1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Frass, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Michael Frass, Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00861432     History of Changes
Other Study ID Numbers: 2341
Study First Received: March 12, 2009
Last Updated: December 28, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Life quality
questionnaire
tumor patients

ClinicalTrials.gov processed this record on August 01, 2014