Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer

Heidelberg University

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Treatments

Drug: two complex naturopathic add-on therapies, leaflet 5-a-day

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00160901

M16

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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