Breast CancerPhase 4NCT00160901
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
A Phase 4 study testing two complex naturopathic add-on therapies, leaflet 5-a-day in people with Breast Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- two complex naturopathic add-on therapies, leaflet 5-a-day
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Dec 2005
- Phase
- Phase 4
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for chemotherapy for breast cancer for at least 3 cycles
Who cannot join
- Prior chemotherapy within 12 months
- use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial
- allergy to study medication
- Selenium intoxication
- Current use of cumarins or other medication influencing the coagulation system
- Edema in case of impaired cardial or renal function
Show all 9Show fewer
- Other severe medical condition
- Psychiatric or central neurological disorders
- Regular fluid intake < 2000 ml per day
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Wurttemberg, D-69115
About this study
Official title: Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.
Read the detailed description
patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group.
Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.
- Conditions
- Breast Cancer
- Being tested
- two complex naturopathic add-on therapies, leaflet 5-a-day
- Keywords
- Breast cancer, Chemotherapy, Phytotherapy, Nutritional counseling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two complex naturopathic add-on therapies, leaflet 5-a-dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the sum score of the most common side effects of a chemotherapy (fatigue, nausea, loss of appetite, constipation, diarrhea) measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy
Secondary outcomes (7)
Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy
Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy
Sensitivities measured by the perimed sensitivity questionnaire
Creatinin
ALAT
Coagulation time
Selenium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Hector-Stiftung, Cefak KG, Kempten, Ursapharm, Saarbrücken, Schwabe-Wenex International Ltd
- Investigators
- Cornelia U. von Hagens, MD, Principal investigator, Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160901
- Sponsor's protocol ID
- M16
- Status last verified
- Mar 2007
- First submitted
- 8 Sep 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
- ClinicalTrials.gov ID
- NCT00160901
- Acronym / sponsor ID
- M16
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Chemotherapy, Phytotherapy, Nutritional counseling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Hector-Stiftung, Cefak KG, Kempten, Ursapharm, Saarbrücken, Schwabe-Wenex International Ltd
- Study start
- Aug 2003
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.
Detailed description
patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group.
Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for chemotherapy for breast cancer for at least 3 cycles
Key exclusion criteria (9 listed)
- Prior chemotherapy within 12 months
- use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial
- allergy to study medication
- Selenium intoxication
- Current use of cumarins or other medication influencing the coagulation system
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 |
|---|---|---|
| two complex naturopathic add-on therapies, leaflet 5-a-day | Drug | – |
Primary outcome
Difference in the sum score of the most common side effects of a chemotherapy (fatigue, nausea, loss of appetite, constipation, diarrhea) measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy
7 secondary outcomes
Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy
Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy
Sensitivities measured by the perimed sensitivity questionnaire
Creatinin
ALAT
Coagulation time
Selenium
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 19 Apr 2007.
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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.
Cornelia U. von Hagens, MD principal investigator
Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing two complex naturopathic add-on therapies, leaflet 5-a-day in people with Breast Cancer, run by Heidelberg University at 1 site in Germany.
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 1 inclusion and 9 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 19 Apr 2007. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in the sum score of the most common side effects of a chemotherapy (fatigue, nausea, loss of appetite, constipation, diarrhea) measured by the EORTC QLQ C30 3-5 weeks after and before 3 cycles of chemotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2007.