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Study of Pravastatin or Pentoxifylline/Tocopherol for Lymphedema and Fibrosis

This study is looking at whether two different treatments can help reduce lymphedema (swelling caused by fluid buildup) and fibrosis (thickening and scarring of tissue) that can happen after radiation therapy. You would receive either pravastatin or a combination of pentoxifylline and tocopherol (vitamin E). Researchers want to see if these treatments can reduce these side effects. To join, you must be at least 18 years old and have oropharyngeal squamous carcinoma (a type of head and neck cancer) that will be treated with radiation. The study aims to enroll 295 people. The main goal is to check the safety and side effects of these treatments over about one year.

Study design
This is an interventional, open-label study that plans to enroll 295 participants. It is a randomized trial, meaning you would be assigned to one of the treatment groups by chance.
What's involved
The primary endpoint for safety and adverse events will be measured through study completion, which is an average of 1 year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and adverse events through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~295 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:PravastatinPentoxifyllineTocopherol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Lymphedema
Fibrosis

Explore related trials

Oropharyngeal Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Clifton Fuller, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Clifton Fuller, MD,PHD
[email protected]
(832) 817-8568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

absolute neutrophil count ≥1,000/mcL
platelets ≥100,000/mcL
total bilirubin ≤ institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤3 x institutional ULN
creatinine ≤1.5 x institutional ULN 6. The effects of pentoxifylline/pravastatin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 7. Ability to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0