RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably.

PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer.

Condition	Treatment or Intervention	Phase
Radiation Fibrosis stage I breast cancer stage II breast cancer stage IIIA breast cancer	Drug: IH636 grape seed proanthocyanidin extract  Procedure: complications of therapy assessment/management  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
• Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• History of early breast cancer
• T1-T3, N0-N1, M0
• No evidence of cancer recurrence
• Palpable breast induration due to prior radiotherapy
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 2 years since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day

United Kingdom, England
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

Study chairs or principal investigators

John Robert Yarnold, MD,  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000069454; RMNHS-GRAPE-1991; RMNHS-1991; EU-20209
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041223
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08