About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pravastatin (drug)
- Pentoxifylline
- ketoprofen
- Pirfenidoneone
- Standard of Care (SOC)
- tocopherol
Treatment groups
Locations
1Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor