TumorPhase 2NCT00861432
Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy
A Phase 2 study testing additive homeopathic treatment in people with Tumor, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- additive homeopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2008to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor patients between 18 and 100 years old
- Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Med. Univ. Vienna, Dept. Internal Med. I
Vienna, State of Vienna, A1090
About this study
Official title: 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.
Read the 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.
- Conditions
- Tumor
- Being tested
- additive homeopathic treatment
- Keywords
- Life quality, questionnaire, tumor patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additive homeopathic treatmentOther
Also called homeopathic remedies according to the Pharmacopoeia
These patients receive additive homeopathic treatment
| Study group | Role | What they receive |
|---|---|---|
| additive homeopathic treatment | Active comparator | These patients receive additive homeopathic treatment during conventional cancer treatment. Receives: Other: additive homeopathic treatment |
| no additive homeopathic treatment | No intervention | These patients do not receive additive homeopathic treatment during conventional cancer treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference with regard to subjective feeling and life quality with or without homeopathic treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Frass, Medical University of Vienna
- Investigators
- Michael Frass, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861432
- Sponsor's protocol ID
- 2341
- Status last verified
- Sep 2016
- First submitted
- 12 Mar 2009
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Frass M, Friehs H, Thallinger C, Sohal NK, Marosi C, Muchitsch I, Gaertner K, Gleiss A, Schuster E, Oberbaum M. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial. Complement Ther Med. 2015 Jun;23(3):309-17. doi: 10.1016/j.ctim.2015.03.004. Epub 2015 Mar 23.
PubMed 26051564
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.
- ClinicalTrials.gov ID
- NCT00861432
- Acronym / sponsor ID
- 2341
- Conditions
- Tumor
- Keywords
- Life quality, questionnaire, tumor patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| additive homeopathic treatment | Active comparator | Other: additive homeopathic treatmentThese patients receive additive homeopathic treatment during conventional cancer treatment. |
| no additive homeopathic treatment | No intervention | –These patients do not receive additive homeopathic treatment during conventional cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tumor patients between 18 and 100 years old
- Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additive homeopathic treatmentAlso: homeopathic remedies according to the PharmacopoeiaThese patients receive additive homeopathic treatment | Other | additive homeopathic treatment |
Primary outcome
Difference with regard to subjective feeling and life quality with or without homeopathic treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Derived from this study: PubMed 26051564Frass M, Friehs H, Thallinger C, Sohal NK, Marosi C, Muchitsch I, Gaertner K, Gleiss A, Schuster E, Oberbaum M. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial. Complement Ther Med. 2015 Jun;23(3):309-17. doi: 10.1016/j.ctim.2015.03.004. Epub 2015 Mar 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frass, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing additive homeopathic treatment in people with Tumor, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference with regard to subjective feeling and life quality with or without homeopathic treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.