Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72553848

Enrollment

Unknown

Registered

2002-10-15

Start date

2001-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast cancer

Interventions

IH636 grape seed proanthocyanidin extract (100 mg) or placebo TDS for 6 months

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Past history of early breast cancer (T1-3 N0-1 M0) 2. Past history of radiotherapy to the breast 3. A minimum of 24 months post radiotherapy 4. No evidence of cancer recurrence 5. Palpable breast induration due to previous radiotherapy 6. Ability to attend The Royal Marsden Hospital, Sutton for assessments 7. Written informed consent

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026