Recruiting
Phase 2

Medication with Radiation Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06912763

Conditions

Fibrosis Syndrome

Lymphedema

Head &Amp; Neck Cancer

Fibrosis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pravastatin (drug)

Pentoxifylline

ketoprofen

Pirfenidoneone

Standard of Care (SOC)

Study Details

Brief 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.

Conditions

Fibrosis Syndrome

Lymphedema

Head &Amp; Neck Cancer

Fibrosis

Study ID

NCT06912763

Start date

Aug 8, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment with Pravastatin QD

40 mg/day for 12 months

experimental: Treatment with Pentoxifylline TID + Tocopherol

400 mg/1000 IU vitamin E for 12 months

experimental: Treatment with Ketoprofen TID

75 mg for 12 months

experimental: Treatment with Pirfenidone TID

801 mg for 12 months

experimental: Treatment with SoC (Control)

No pharmacologic intervention (control)

Interventions

Pravastatin (drug)

Given PO

Pentoxifylline

Given PO

ketoprofen

Given PO

Pirfenidoneone

Given PO

Standard of Care (SOC)

SOC

tocopherol

Given PO

Primary outcome measure

  • Safety and adverse events [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Clifton Fuller, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-24.