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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Radiation Fibrosis

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

John R. Yarnold, MD, FRCR

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000069454

NCT ID:

NCT00041223

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • Radiation Fibrosis
  • radiation fibrosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Fibrosis
  • Radiation Pneumonitis

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