NCT06912763 · M.D. Anderson Cancer Center
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Pravastatin (drug)
Given PO
DRUG
Pentoxifylline
Given PO
DRUG
ketoprofen
Given PO
DRUG
Pirfenidoneone
Given PO
OTHER
Standard of Care (SOC)
SOC
DRUG
tocopherol
Given PO
Primary outcome measures
Safety and adverse events
Time frame: Through study completion; an average of 1 year
Incidence of Adverse of Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligibility Criteria Eligibility criteria (observational registry or randomization)
- Prior history of head and neck cancer with no active disease.
- Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
- Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
- No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
- No history of myopathy/rhabdomyolysis.
- Creatinine clearance \<30mL/min.
- No history of acute myocardial infarction or severe coronary disease.
- Non-pregnant/post-menopausal, or male.
- No history of diabetes mellitus
- Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
- 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
- Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
- History of myopathy/rhabdomyolysis.
- History of acute myocardial infarction or severe coronary disease.
- Pregnant/post-menopausal, or male.
- History of diabetes mellitus.
- Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
- Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Exclusion criteria
- Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
- History of myopathy/rhabdomyolysis.
- History of acute myocardial infarction or severe coronary disease.
- Pregnant/post-menopausal, or male.
- History of diabetes mellitus.
- Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
- Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations