Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
- Conditions
- Fibrosis SyndromeLymphedemaHead &Amp; Neck CancerFibrosis
- Interventions
- Drug: PirfenidoneoneOther: Standard of Care (SOC)
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment with Pravastatin QD Pravastatin (drug) 40 mg/day for 12 months Treatment with Pirfenidone TID Pirfenidoneone 801 mg for 12 months Treatment with Pentoxifylline TID + Tocopherol Pentoxifylline 400 mg/1000 IU vitamin E for 12 months Treatment with Ketoprofen TID ketoprofen 75 mg for 12 months Treatment with Pentoxifylline TID + Tocopherol tocopherol 400 mg/1000 IU vitamin E for 12 months Treatment with SoC (Control) Standard of Care (SOC) No pharmacologic intervention (control)
- Primary Outcome Measures
Name Time Method Safety and adverse events Through 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
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center🇺🇸Houston, Texas, United StatesClifton Fuller, MDPrincipal Investigator