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RecruitingNCT06912763Updated Jul 24, 2026

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

A Phase 2 interventional study of Pravastatin (drug) and Pentoxifylline in Fibrosis Syndrome, Lymphedema and Head &Amp; Neck Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Sex
Female
01

Study summary

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.

Read the detailed description

Primary Objectives

  1. Determine the relative utility of candidate agents to reduce clinician-rated radiation lymphedema/fibrosis

    1. Hyp 1: Participants receiving candidate agent(s) will exhibit a proportional lower rate of Common Toxicity Criteria- Adverse Event (CTC-AE v5.0) rating of Grade 2 or greater on either "Fibrosis deep connective tissue" or "Superficial soft tissue fibrosis" by formal clinician assessment at 12 months post-randomization.
    2. Hyp 2: Participants receiving candidate agent(s) will exhibit a proportional lower rate of objective lymphedema/fibrosis rated as "moderate/severe" grade at any head and neck subsite as measured by the Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Assessment Criteria by a certified lymphedema specialist at 12 months post-randomization.

  2. Determine the relative effect size observed of candidate agent(s) to reduce objective imaging-derived measures of radiation lymphedema/fibrosis-related sequalae [Primary]

    1. Hyp 3: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of objective DIGEST-detected swallowing dysfunction 12 months post-randomization.
    2. Hyp 4: Participants receiving candidate agent(s) will exhibit a proportional lower rate of objective MRI-detected difference between 6- and 18-month post-randomization quantitative T1 (T1 mapping) intensity for paired muscle swallowing/neck/masticator muscles receiving >=40Gy post-randomization.

Secondary Objectives

  1. Determine the relative effect size observed of candidate agent(s) to reduce patient reported measures of toxicity associated with lymphedema/fibrosis-related sequalae [Secondary]

    1. Hyp 5: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe rated items "Fibrosis deep connective tissue" or "Superficial soft tissue fibrosis" by patient self-assessment using the Participant Reported Outcomes-CTCAE (PROCTCAE) Scale at 12-months post-randomization.
    2. Hyp 6: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe rated symptom items by participant self-assessment using the Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Symptom Inventory Scale at 12-months post-randomization.
    3. Hyp 7: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe global symptom burden by participant self-assessment using the MD Anderson Symptom Inventory Scale at 12-months post-randomization.

    4. Hyp 8: Participants receiving candidate agent(s) will exhibit a proportionally improved global quality of life as denoted by patient self-assessment using the EQ-5D Visual analogue Scale at 12-months post-randomization.

      .

02

Conditions studied

  • Fibrosis Syndrome
  • Lymphedema
  • Head &Amp; Neck Cancer
  • Fibrosis
03

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's planned enrollment of 250 is above the median of 50 across 369 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Browse M.D. Anderson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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 ( class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
  5. No history of myopathy/rhabdomyolysis.
  6. \<30mL/min.
  7. No history of acute myocardial infarction or severe coronary disease.
  8. Non-pregnant/, or male.
  9. No history of diabetes mellitus
  10. Allergy/ to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
  11. No 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Treatment with Pravastatin QD

    40 mg/day for 12 months

    Drug: Pravastatin (drug)

  • Experimental
    Treatment with Pentoxifylline TID + Tocopherol

    400 mg/1000 IU vitamin E for 12 months

    Drug: Pentoxifylline · Drug: tocopherol

  • Experimental
    Treatment with Ketoprofen TID

    75 mg for 12 months

    Drug: ketoprofen

  • Experimental
    Treatment with Pirfenidone TID

    801 mg for 12 months

    Drug: Pirfenidoneone

  • Experimental
    Treatment with SoC (Control)

    No pharmacologic intervention (control)

    Other: Standard of Care (SOC)

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and adverse events

    Incidence of Adverse of Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Jul 2030, 59 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2025
First posted
Apr 6, 2025
StartActual
Aug 8, 2025
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2031
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06912763
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Apr 6, 2025
Start date
Aug 8, 2025
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2031 (estimated)
Last update
Jul 24, 2026

Study contacts

Clifton Fuller, MD
Contact
cdfuller@mdanderson.org
(832) 817-8568
Clifton Fuller, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Pravastatin · Pentoxifylline · Ketoprofen · Tocopherols

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