Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy
Phase 2
Completed
- Conditions
- Breast cancerCancer
- Registration Number
- ISRCTN72553848
- Lead Sponsor
- The Royal Marsden NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 0
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration