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

PHASE2RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

March 1, 2031

Study Completion Date

March 1, 2033

Conditions
Fibrosis SyndromeLymphedemaHead &Amp; Neck CancerFibrosis
Interventions
DRUG

Pravastatin (drug)

Given PO

DRUG

Pentoxifylline

Given PO

DRUG

ketoprofen

Given PO

DRUG

Pirfenidoneone

Given PO

OTHER

Standard of Care (SOC)

SOC

DRUG

tocopherol

Given PO

Trial Locations (1)

77030

RECRUITING

MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT06912763 - Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) | Biotech Hunter | Biotech Hunter