| Source of record | UK Trials |
| ISRCTN | ISRCTN45257322 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | SP2313/0201 |
| Public title | Double-blind, placebo controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Past history of early breast cancer (T1-3 N0 M0)
2. No axillary surgery or lower axillary sampling only
3. Radiotherapy to the breast/chest wall plus axilla and or stem cell factor (SCF)
4. A minimum of 5 years post-radiotherapy
5. No evidence of cancer recurrence
6. Disabilities due to previous radiotherapy
7. Ability to attend RMT Sutton for assessments
8. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/12/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. DL-Alpha Tocopheryl Acetate 500 mg (or placebo) po BD for 6 months
2. Oxpentifylline 400 mg (or placebo) po BD for 6 months |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45257322 |
| Date last extracted from ISRCTN register | 17/04/2008 |
