NCT00041223

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.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 6, 2013

Status Verified

September 1, 2002

First QC Date

July 8, 2002

Last Update Submit

November 5, 2013

Conditions

Breast CancerRadiation Fibrosis

Keywords

radiation fibrosisstage I breast cancerstage II breast cancerstage IIIA breast cancer

Interventions

IH636 grape seed proanthocyanidin extractDIETARY_SUPPLEMENT

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsRadiation Fibrosis Syndrome

Interventions

Grape Seed Proanthocyanidins

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRadiation InjuriesWounds and Injuries

Study Officials

  • John R. Yarnold, MD, FRCR

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Last Updated

November 6, 2013

Record last verified: 2002-09

Locations

GB(1)