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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)

Phase 2
Not yet recruiting
Conditions
Fibrosis Syndrome
Lymphedema
Head &Amp; Neck Cancer
Fibrosis
Interventions
Registration Number
NCT06912763
Lead Sponsor
M.D. Anderson Cancer Center
Brief 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.

Detailed Description

Primary Objectives

1. Determine the relative utility of candidate agents to reduce clinician-rated radiation lymphedema/fibrosis

1. Hyp 1: Participants receiving candidate agent(s) will exhibit a proportional lower rate of Common Toxicity Criteria- Adverse Event (CTC-AE v5.0) rating of Grade 2 or greater on either "Fibrosis deep connective tissue" or "Superficial soft tissue fibrosis" by formal clinician assessment at 12 months post-randomization.

2. Hyp 2: Participants receiving candidate agent(s) will exhibit a proportional lower rate of objective lymphedema/fibrosis rated as "moderate/severe" grade at any head and neck subsite as measured by the Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Assessment Criteria by a certified lymphedema specialist at 12 months post-randomization.

2. Determine the relative effect size observed of candidate agent(s) to reduce objective imaging-derived measures of radiation lymphedema/fibrosis-related sequalae \[Primary\]

1. Hyp 3: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of objective DIGEST-detected swallowing dysfunction 12 months post-randomization.

2. Hyp 4: Participants receiving candidate agent(s) will exhibit a proportional lower rate of objective MRI-detected difference between 6- and 18-month post-randomization quantitative T1 (T1 mapping) intensity for paired muscle swallowing/neck/masticator muscles receiving \>=40Gy post-randomization.

Secondary Objectives

1. Determine the relative effect size observed of candidate agent(s) to reduce patient reported measures of toxicity associated with lymphedema/fibrosis-related sequalae \[Secondary\]

1. Hyp 5: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe rated items "Fibrosis deep connective tissue" or "Superficial soft tissue fibrosis" by patient self-assessment using the Participant Reported Outcomes-CTCAE (PROCTCAE) Scale at 12-months post-randomization.

2. Hyp 6: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe rated symptom items by participant self-assessment using the Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Symptom Inventory Scale at 12-months post-randomization.

3. Hyp 7: Participants receiving candidate agent(s) will exhibit a proportionally lower rate of moderate-severe global symptom burden by participant self-assessment using the MD Anderson Symptom Inventory Scale at 12-months post-randomization.

4. Hyp 8: Participants receiving candidate agent(s) will exhibit a proportionally improved global quality of life as denoted by patient self-assessment using the EQ-5D Visual analogue Scale at 12-months post-randomization.

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Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
250
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Treatment with Pravastatin QDPravastatin (drug)40 mg/day for 12 months
Treatment with Pirfenidone TIDPirfenidoneone801 mg for 12 months
Treatment with Pentoxifylline TID + TocopherolPentoxifylline400 mg/1000 IU vitamin E for 12 months
Treatment with Ketoprofen TIDketoprofen75 mg for 12 months
Treatment with Pentoxifylline TID + Tocopheroltocopherol400 mg/1000 IU vitamin E for 12 months
Treatment with SoC (Control)Standard of Care (SOC)No pharmacologic intervention (control)
Primary Outcome Measures
NameTimeMethod
Safety and adverse eventsThrough study completion; an average of 1 year

Incidence of Adverse of Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Clifton Fuller, MD
Principal Investigator

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