Double-blind, placebo-controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis
| ISRCTN | ISRCTN45257322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45257322 |
| ClinicalTrials.gov number | NCT00022204 |
| Secondary identifying numbers | SP2313/0201 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 25/01/2019
- 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
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Double-blind placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Double-blind, placebo-controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis |
| 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 | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Alpha-tocopherol, oxpentifylline |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/11/2004 | 25/01/2019 | Yes | No |
Editorial Notes
25/01/2019: Publication reference added
