NCT06494111

Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 295 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.

Detailed description

* Primary Objectives Determine the relative utility of pentoxifylline/tocopherol or pravastatin to reduce clinician-rated radiation lymphedema/fibrosis. * Secondary Objectives Determine the relative effect size observed of pentoxifylline/tocopherol or pravastatin to reduce objective imaging-derived measures of radiation lymphedema/fibrosis-related sequalae. Determine the relative effect size observed of pentoxifylline/tocopherol or pravastatin to reduce patient-reported measures of toxicity associated with lymphedema/fibrosis-related sequalae.

Conditions

• Lymphedema
• Fibrosis

Interventions

Type	Name	Description
DRUG	Pravastatin	Given by PO
DRUG	Pentoxifylline	Given by PO
DRUG	Tocopherol	Given by PO

Timeline

• Start date: 2025-02-13
• Primary completion: 2029-05-01
• Completion: 2031-03-01
• First posted: 2024-07-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study