Recruiting
Phase 2

Pentoxifylline & Vitamin E

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06494111

Conditions

Lymphedema

Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pravastatin

Pentoxifylline

Tocopherol

Study Details

Brief summary:

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

Conditions

Lymphedema

Fibrosis

Study ID

NCT06494111

Start date

Feb 13, 2025

Status verified date

Feb, 2026

Completion date

Mar 1, 2031

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Untreated T0-T4N0-3M0 oropharyngeal squamous carcinoma.

1. Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s).
2. Creatinine clearance >30mL/min
3. 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
4. ECOG performance status ≤2 (Karnofsky ≥60%,)
5. 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
6. The effects of pentoxifylline/pravastatin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following.

  • 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.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
2. History of myopathy/rhabdomyolysis.
3. History of acute myocardial infarction or severe coronary disease.
4. Pregnant/post-menopausal, or male.
5. History of diabetes mellitus.
6. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
7. Contraindications for MRI
8. Participants who are receiving any other investigational agents.
9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
10. Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Study Design

Enrollment

295 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group 1

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

experimental: Group 2

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

no intervention: Group 3

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

Interventions

Pravastatin

Given by PO

Pentoxifylline

Given by PO

Tocopherol

Given by PO

Primary outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Clifton Fuller, MD,PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-02-13.