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

Tracking Information

First Received Date ^ICMJE

July 8, 2002

Last Updated Date

May 9, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00041223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Breast Cancer
Radiation Fibrosis

Intervention ^ICMJE

Dietary Supplement: IH636 grape seed proanthocyanidin extract

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00041223

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069454, RMNHS-GRAPE-1991, RMNHS-1991, EU-20209

Study Sponsor ^ICMJE

Royal Marsden - London

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

John R. Yarnold, MD, FRCR

Royal Marsden - Surrey

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP