NCT00160901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 19, 2007

Status Verified

March 1, 2007

First QC Date

September 8, 2005

Last Update Submit

April 18, 2007

Conditions

Breast Cancer

Keywords

Breast cancerChemotherapyPhytotherapyNutritional counseling

Outcome Measures

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 (7)

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

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

  • Sensitivities measured by the perimed sensitivity questionnaire

  • Creatinin

  • ALAT

  • +2 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for chemotherapy for breast cancer for at least 3 cycles

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Complementary and Integrative Medicine

Heidelberg, Baden-Wurttemberg, D-69115, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cornelia U. von Hagens, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2003

Study Completion

December 1, 2005

Last Updated

April 19, 2007

Record last verified: 2007-03

Locations

DE(1)