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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Cornelia U. von Hagens, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Complementary and Integrative Medicine Women's Hospital, University of Heidelberg

Locations

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Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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M16

Identifier Type: -

Identifier Source: org_study_id