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Completed

NCT Number: NCT00160901

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, D-69115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. 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

  1. Difference in general QOL 3-5 weeks after and before three cycles of chemotherapy

  2. Difference in anxiety and depression measured by HADS-D 3-5 weeks after and before three cycles of chemotherapy

  3. Sensitivities measured by the perimed sensitivity questionnaire

  4. Creatinin

  5. ALAT

  6. Coagulation time

  7. Selenium

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Cefak KG, Kempten
  • Hector-Stiftung
  • Schwabe-Wenex International Ltd
  • Ursapharm, Saarbrücken

Registry information

Official study title

Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg

Important dates

Study start
2003
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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