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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06912763
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pravastatin (drug) — DRUG
    Given PO
  • Pentoxifylline — DRUG
    Given PO
  • ketoprofen — DRUG
    Given PO
  • Pirfenidoneone — DRUG
    Given PO
  • Standard of Care (SOC) — OTHER
    SOC
  • tocopherol — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 8, 2025
Status verified
Oct 2025
Primary completion
Mar 1, 2031
Completion
Mar 1, 2033

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment with Pravastatin QD
    40 mg/day for 12 months
  • Experimental: Treatment with Pentoxifylline TID + Tocopherol
    400 mg/1000 IU vitamin E for 12 months
  • Experimental: Treatment with Ketoprofen TID
    75 mg for 12 months
  • Experimental: Treatment with Pirfenidone TID
    801 mg for 12 months
  • Experimental: Treatment with SoC (Control)
    No pharmacologic intervention (control)

Primary Outcome Measure

Safety and adverse events [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Clifton Fuller, MD
[email protected]
832-817-8568
Clifton Fuller, MD (PRINCIPAL_INVESTIGATOR)

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MD Anderson Cancer Center· Houston, TX

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