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

• Sponsor: Royal Marsden NHS Foundation Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00041223
• Collaborator: (none)
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer; Radiation Fibrosis	Dietary Supplement: IH636 grape seed proanthocyanidin extract	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Supportive Care
• Official Title: Double-Blind, Placebo-Controlled, Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract (GSPE) in Patients With Adverse Effects of High Dose Breast Radiotherapy
• Study Start Date: Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Marsden Hospital	Sutton	England	United Kingdom	SM2 5PT

Sponsors and Collaborators

• Royal Marsden NHS Foundation Trust

Investigators

• Study Chair: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00041223
• Other Study ID Numbers: CDR0000069454; RMNHS-GRAPE-1991; RMNHS-1991; EU-20209
• First Posted: Jan 27, 2003
• Last Update Posted: Nov 6, 2013
• Last Verified: Sep 1, 2002

• Keywords provided by , ,: radiation fibrosis; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Radiation Pneumonitis; Fibrosis; Proanthocyanidin; Procyanidin

Study Results

No Results Posted as of Nov 6, 2013