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

NCT06912763 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Fibrosis Syndrome
  • Lymphedema
  • Head &Amp; Neck Cancer
  • Fibrosis

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Clifton Fuller, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2031-03-01
Completion
2033-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912763 on ClinicalTrials.gov