Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorM.D. Anderson Cancer Center

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

250 Participants
are divided into 5 treatment groups

Locations

1
MD Anderson Cancer Center77030, HoustonTexas, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor