Double-blind, placebo-controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Double-blind placebo-controlled randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Alpha-tocopherol, oxpentifylline
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2001

Participant type(s)	Patient
Age group	Adult
Sex	Female
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2004	25/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

25/01/2019: Publication reference added