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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45257322
Enrollment
Unknown
Registered
2001-07-01
Start date
1996-01-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

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

Sponsors

Cancer Research UK (CRUK) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026