Can common drugs stop radiation damage? new trial aims to prevent lymphedema
NCT ID NCT06494111
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether pravastatin (a cholesterol drug) or a combination of pentoxifylline and vitamin E can prevent lymphedema and fibrosis (swelling and scarring) caused by radiation therapy in head and neck cancer patients. About 295 adults with oropharyngeal cancer who are scheduled for radiation will take one of the drug regimens. The study aims to see if these treatments can reduce long-term complications and improve quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pravastatin, Pentoxifylline, and Vitamin E
- What this could lead to
- If successful, this could offer a simple, low-cost way to prevent long-term swelling and scarring after radiation therapy for head and neck cancer.
- What could go wrong
- This is an early phase 2 trial with only 295 participants, so results may not apply to everyone. The drugs may cause side effects or fail to prevent fibrosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 295 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: • Untreated T0-T4N0-3M0 oropharyngeal squamous carcinoma. 1. Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s). 2. Creatinine clearance \>30mL/min 3. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of pentoxifylline/pravastatin in participants \<18 years of age, children are excluded from this study 4. ECOG performance status ≤2 (Karnofsky ≥60%,) 5. Participants must have adequate organ and marrow function as defined below * 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. Exclusion Criteria: 1. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism. 2. History of myopathy/rhabdomyolysis. 3. History of acute myocardial infarction or severe coronary disease. 4. Pregnant/post-menopausal, or male. 5. History of diabetes mellitus. 6. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine. 7. Contraindications for MRI 8. Participants who are receiving any other investigational agents. 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study 10. Participants with psychiatric illness/social situations that would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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