Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy
| ISRCTN | ISRCTN72553848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72553848 |
| Protocol serial number | RMH1991 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- Submission date
- 15/10/2002
- Registration date
- 15/10/2002
- Last edited
- 05/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | IH636 grape seed proanthocyanidin extract (100 mg) or placebo TDS for 6 months |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | IH636 grape seed proanthocyanidin (GSPE) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 10/10/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
