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

NCT06912763 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1521NCI-2025-02225
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events

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

  Through study completion; an average of 1 year

Study Arms (5)

Treatment with Pravastatin QD

EXPERIMENTAL

40 mg/day for 12 months

Drug: Pravastatin (drug)

Treatment with Pentoxifylline TID + Tocopherol

EXPERIMENTAL

400 mg/1000 IU vitamin E for 12 months

Drug: Pentoxifylline; Drug: tocopherol

Treatment with Ketoprofen TID

EXPERIMENTAL

75 mg for 12 months

Drug: ketoprofen

Treatment with Pirfenidone TID

EXPERIMENTAL

801 mg for 12 months

Drug: Pirfenidoneone

Treatment with SoC (Control)

EXPERIMENTAL

No pharmacologic intervention (control)

Other: Standard of Care (SOC)

Interventions

Pravastatin (drug) DRUG

Given PO

Treatment with Pravastatin QD

Pentoxifylline DRUG

Given PO

Treatment with Pentoxifylline TID + Tocopherol

ketoprofen DRUG

Given PO

Treatment with Ketoprofen TID

Pirfenidoneone DRUG

Given PO

Treatment with Pirfenidone TID

Standard of Care (SOC) OTHER

SOC

Treatment with SoC (Control)

tocopherol DRUG

Given PO

Treatment with Pentoxifylline TID + Tocopherol

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
• History of myopathy/rhabdomyolysis.
• History of acute myocardial infarction or severe coronary disease.
• Pregnant/post-menopausal, or male.
• History of diabetes mellitus.
• Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
• Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
• Participants who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphedema; Head and Neck Neoplasms; Fibrosis

Interventions

Pravastatin; Pharmaceutical Preparations; Pentoxifylline; Ketoprofen; Standard of Care; Tocopherols

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Clifton Fuller, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clifton Fuller, MD

CONTACT

(832) 817-8568; cdfuller@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: January 26, 2026

Record last verified: 2025-10

Locations

US (1)