Drug Therapy for Head and Neck Cancer

Overseen by Clifton Fuller, MD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clifton Fuller, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for survivors of head and neck cancers who have developed lymphedema or fibrosis due to radiation therapy. Participants should be experiencing related symptoms like thyroid fibrosis, primary lymphedema, or postprandial fullness syndrome.

Inclusion Criteria

I've had neck radiotherapy with a dose of 30Gy or more.

I had head and neck cancer but am currently free of active disease.

My kidney function is low, with a creatinine clearance under 30 mL/min.

Exclusion Criteria

Contraindications for MRI subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional

I do not have severe liver disease, cirrhosis, or active alcoholism.

I have had a heart attack or severe heart disease.

Treatment Details

Interventions

• Ketoprofen (Nonsteroidal Anti-inflammatory Drug)
• Pentoxifylline (Anti-fibrotic agents)
• Pirfenidone (Anti-fibrotic agents)
• Pravastatin (Anti-fibrotic agents)

Trial Overview The study tests if Pravastatin, Pentoxifylline, Pirfenidoneone, ketoprofen, tocopherol can improve or prevent radiation-related lymphedema and/or fibrosis compared to Standard of Care (SOC). It's a randomized-controlled trial with adaptive elements.

Participant Groups

Group I: Treatment with SoC (Control) Experimental Treatment 1 Intervention

No pharmacologic intervention (control)

Group II: Treatment with Pravastatin QD Experimental Treatment 1 Intervention

40 mg/day for 12 months

Group III: Treatment with Pirfenidone TID Experimental Treatment 1 Intervention

801 mg for 12 months

Group IV: Treatment with Pentoxifylline TID + Tocopherol Experimental Treatment 2 Interventions

400 mg/1000 IU vitamin E for 12 months

Group V: Treatment with Ketoprofen TID Experimental Treatment 1 Intervention

75 mg for 12 months

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine