IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

Royal Marsden NHS Foundation Trust

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer; Radiation Fibrosis

Treatments: Dietary Supplement: IH636 grape seed proanthocyanidin extract

Study type: Interventional

Funder types: Other

Identifiers

NCT00041223

RMNHS-1991

RMNHS-GRAPE-1991

CDR0000069454

EU-20209

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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