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Can old drugs stop Radiation's lingering damage? new trial aims to find out

NCT ID NCT06912763

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This phase 2 trial tests several medications—including pravastatin, pentoxifylline, and others—to see if they can treat or prevent lymphedema and fibrosis caused by radiation therapy in head and neck cancer survivors. About 250 participants who have finished radiation at least 6 months ago and have swelling or tissue hardening will be randomly assigned to one of the drugs or standard care. The goal is to find the safest and most effective option to ease these long-term side effects.

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, Ketoprofen, Pirfenidone, Tocopherol
What this could lead to
If successful, this could identify an effective drug combination to reverse or prevent painful swelling and tissue hardening after radiation, improving quality of life for head and neck cancer survivors.
What could go wrong
This is a mid-stage trial with multiple drugs, so it is unclear which, if any, will work. Side effects like muscle pain or liver issues are possible, and results may not apply to all patients.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Eligibility Criteria Eligibility criteria (observational registry or randomization) 1. Prior history of head and neck cancer with no active disease. 2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s) 3. Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy. 4. No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers. 5. No history of myopathy/rhabdomyolysis. 6. Creatinine clearance \<30mL/min. 7. No history of acute myocardial infarction or severe coronary disease. 8. Non-pregnant/post-menopausal, or male. 9. No history of diabetes mellitus 10. Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine 11. No contraindications for magnetic resonance imaging a Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional 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 Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional 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.

Fibrosis head and neck cancer Head and Neck Neoplasms lymphedema

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.