Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00022204
Protocol/serial number
SP2313/0201
Study information
Scientific title
Double-blind, placebo-controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Double-blind placebo-controlled randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Alpha-tocopherol, oxpentifylline
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2004 results in https://www.ncbi.nlm.nih.gov/pubmed/15542159 (added 25/01/2019)