Clinical trial NCT00160901: Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
Official title: Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy
Phytotherapy
Nutritional counseling
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Hector-Stiftung
name: Cefak KG, Kempten
name: Ursapharm, Saarbrücken
name: Schwabe-Wenex International Ltd
First posted: 2005-09-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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:
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: Coagulation time
measure: Selenium
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Complementary and Integrative Medicine
state: Baden-Württemberg
Study officials:
affiliation: Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg
name: Cornelia U. von Hagens, MD
role: PRINCIPAL_INVESTIGATOR
References: