Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy - Full Text View

Sponsor:	Medical University of Vienna
Information provided by (Responsible Party):	Michael Frass, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00861432

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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 May 23, 2012