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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06494111
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fibrosis
  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pravastatin — DRUG
    Given by PO
  • Pentoxifylline — DRUG
    Given by PO
  • Tocopherol — DRUG
    Given by PO

Study Details

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

Key Dates

Start date
Feb 13, 2025
Status verified
Feb 2026
Primary completion
May 1, 2029
Completion
Mar 1, 2031

Study Design

Enrollment
295 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group 1
    Beginning at 6 months after radiation therapy, participants will take 40 mg pravastatin by mouth 1 time a day for about 12 months.
  • Experimental: Group 2
    Beginning at 6 months after radiation therapy, participants will take pentoxifylline and vitamin E by mouth 3 times a day for about 12 months.
  • No Intervention: Group 3
    Participants will not be given any of the study drugs, as this is the control group.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Clifton Fuller, MD,PHD
[email protected]
832-817-8568
Clifton Fuller, MD,PHD (PRINCIPAL_INVESTIGATOR)

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MD Anderson Cancer Center· Houston, TX

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