Clinical trial · Interventional
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
NCT00160901CI-TRIAL-00000684completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| two complex naturopathic add-on therapies, leaflet 5-a-day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
Secondary outcomes (7)
- measure
- Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy
- measure
- Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy
- measure
- Sensitivities measured by the perimed sensitivity questionnaire
- measure
- Creatinin
- measure
- ALAT
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for chemotherapy for breast cancer for at least 3 cycles Exclusion Criteria: * 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 * Other severe medical condition * Psychiatric or central neurological disorders * Regular fluid intake \< 2000 ml per day
References
Publications (0)
Data not yet available
No reference posted for this study.