Actively Recruiting
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)
Led by M.D. Anderson Cancer Center · Updated on 2026-02-13
295
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated T0-T4N0-3M0 oropharyngeal squamous carcinoma
- Planned radiotherapy with prescribed dose to unilateral or bilateral neck(s)
- Creatinine clearance greater than 30 mL/min
- Age 18 years or older
- ECOG performance status 0, 1, or 2 (Karnofsky 60% or higher)
- Adequate organ and marrow function with absolute neutrophil count at least 1,000/mcL
- Platelets at least 100,000/mcL
- Total bilirubin within normal institutional limits
- AST/ALT up to 3 times upper limit of normal
- Creatinine up to 1.5 times upper limit of normal
- Women of child-bearing potential must agree to use effective contraception during the study
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Active liver disease including Child-Pugh class B or C, cirrhosis, or active alcoholism
- History of myopathy or rhabdomyolysis
- History of acute myocardial infarction or severe coronary disease
- Pregnant, post-menopausal, or male participants
- History of diabetes mellitus
- Allergy or hypersensitivity to HMG Co-A reductase inhibitors or xanthine derivatives
- Contraindications for MRI
- Current use of other investigational agents
- History of allergic reactions to statins, hemorheologic agents, or related compounds
- Psychiatric illness or social situations limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Clifton Fuller, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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