Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Pentoxifylline and Vitamin E for Chronic Breast Pain Post-Radiotherapy
NCT00188669Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 2002
- Countries
- 1
- Sponsor
- University Health Network
- Modality
- Small Molecules
- Drugs
- pentoxifylline
- Conditions
- radiation-induced fibrosis (RIF)mastalgia
01
Overview
Phase 2, open-label, single-arm trial of pentoxifylline in radiation-induced fibrosis (RIF) and mastalgia, sponsored by University Health Network. Primary endpoints: Improvement in breast pain with use of the interventional agents and Improvement in patient function with the use of the interventional agents. Started Jul 2002; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Experimental Arm
Pentoxifylline + alpha-Tocopherol
03
Who it enrols
Women aged 18-75 with UICC TNM stage 0-2 breast cancer treated with conservative surgery and adjuvant radiotherapy, presenting with chronic breast pain or tenderness (LAS >= 3cm) 3 months to 3 years post-radiation.
04
Endpoints
Primary
Improvement in breast pain with use of the interventional agents
Improvement in patient function with the use of the interventional agents
Secondary
Time to maximal improvement in pain
Durability of response
Quality of life changes during the study
Qualitatively characterise presenting pain syndromes
Examine techniques for objective assessment of breast edema and texture/fibrotic changes
Investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured
Beyond the preview
Go deeper on NCT00188669.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00188669.