Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

NCT06494111 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0968NCI-2024-05763
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.

Conditions

Lymphedema; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (3)

Group 1

EXPERIMENTAL

Beginning at 6 months after radiation therapy, participants will take 40 mg pravastatin by mouth 1 time a day for about 12 months.

Drug: Pravastatin

Group 2

EXPERIMENTAL

Beginning at 6 months after radiation therapy, participants will take pentoxifylline and vitamin E by mouth 3 times a day for about 12 months.

Drug: Pentoxifylline; Drug: Tocopherol

Group 3

NO INTERVENTION

Participants will not be given any of the study drugs, as this is the control group.

Interventions

Pravastatin DRUG

Given by PO

Group 1

Pentoxifylline DRUG

Given by PO

Group 2

Tocopherol DRUG

Given by PO

Also known as: Vitamin E

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated T0-T4N0-3M0 oropharyngeal squamous carcinoma.
• Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s).
• Creatinine clearance \>30mL/min
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of pentoxifylline/pravastatin in participants \<18 years of age, children are excluded from this study
• ECOG performance status ≤2 (Karnofsky ≥60%,)
• Participants must have adequate organ and marrow function as defined below
• absolute neutrophil count ≥1,000/mcL
• platelets ≥100,000/mcL
• total bilirubin ≤ institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤3 x institutional ULN
• creatinine ≤1.5 x institutional ULN
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure.

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
• 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; Fibrosis

Interventions

Pravastatin; Pentoxifylline; Tocopherols; Vitamin E

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; 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; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Clifton Fuller, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clifton Fuller, MD,PHD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): March 1, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)