This phase II trial compares the effect of pravastatin, pentoxifylline with tocopherol, ketoprofen and pirfenidone on radiation therapy related lymphedema and/or fibrosis in head and neck cancer survivors. Pravastin is the active ingredient in a drug used to lower the amount of cholesterol in the blood and to prevent stroke and heart attack. It is also being studied in the treatment of cancer and other conditions. Pravastatin blocks an enzyme that helps make cholesterol in the body. It may also make tumor cells more sensitive to anticancer drugs. It is a type of HMG-CoA reductase inhibitor, a type of statin, and a type of chemosensitizer. It has also been shown to reduce radiation related fibrosis. Pentoxifylline is a drug used to prevent blood clotting and as a treatment that may help decrease weight loss in people with cancer. Tocopherol is class of vitamin E compounds naturally found in many different sources, such as oils, nuts, and vegetables. Tocopherols have antioxidant activity. Pentoxifylline and tocopherol together may also help decrease fibrosis. Ketoprofen, a type of anti-inflammatory drug, stops the body from making substances that cause pain and inflammation and may help reduce lymphedema. Pirfenidone, an anti-inflammatory drug, is a substance that is being studied in the prevention and treatment of scar tissue caused by radiation therapy. This study may help determine whether adding pravastatin, pentoxifylline with tocopherol, ketoprofen or pirfenidone may be effective in improving or limiting the side effects of radiation-related lymphedema and/or fibrosis in head and neck cancer survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT06912763.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Clifton David Fuller
Phone: 713-794-1974
PRIMARY OBJECTIVES:
I. Determine the relative utility of candidate agents to reduce clinician-rated radiation lymphedema/fibrosis.
II. Determine the relative effect size observed of candidate agent(s) to reduce objective imaging-derived measures of radiation lymphedema/fibrosis-related sequalae.
SECONDARY OBJECTIVES:
I. Determine the relative effect size observed of candidate agent(s) to reduce patient reported measures of toxicity associated with lymphedema/fibrosis-related sequalae.
II. Determine the longitudinal trajectory of all endpoints of interest.
OUTLINE: Patients are randomized to 1 of 5 arms. After 100 patients have been enrolled, the arm with the fewest responses will be closed to new enrollment and the next 80 patients will be randomized to 1 of the 4 remaining arms. After 180 patients have been enrolled, the arm with the worst-performing drug will be closed to new enrollment and further patients will be randomized to 1 of the 3 remaining arms.
ARM I: Patients receive pravastatin orally (PO) once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive referral for standard of care symptomatic lymphedema and fibrosis treatment on study.
ARM II: Patients receive pentoxifylline PO thrice daily (TID) and tocopherol PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive referral for standard of care symptomatic lymphedema and fibrosis treatment on study.
ARM III: Patients receive ketoprofen PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive referral for standard of care symptomatic lymphedema and fibrosis treatment on study.
ARM IV: Patients receive pirfenidone PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive referral for standard of care symptomatic lymphedema and fibrosis treatment on study.
ARM V: Patients receive referral for standard of care symptomatic lymphedema and fibrosis treatment on study.
Additionally, patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI), and carotid ultrasound throughout the study.
After completion of study treatment, patients are followed every 3-6 months for up to 12 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorClifton David Fuller
