Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy
September 12, 2016 updated by: Michael Frass, Medical University of Vienna
Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, A1090
- Med. Univ. Vienna, Dept. Internal Med. I
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Tumor patients between 18 and 100 years old
Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: additive homeopathic treatment
These patients receive additive homeopathic treatment during conventional cancer treatment.
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These patients receive additive homeopathic treatment
Other Names:
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NO_INTERVENTION: no additive homeopathic treatment
These patients do not receive additive homeopathic treatment during conventional cancer treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Difference with regard to subjective feeling and life quality with or without homeopathic treatment
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Frass, MD, Medical University Vienna
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
March 12, 2009
First Submitted That Met QC Criteria
March 12, 2009
First Posted (ESTIMATE)
March 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 13, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.