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Prevention study for Lymphedema
Official title 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)
ClinicalTrials.gov ID: NCT06494111
What this study is testing
What is Pravastatin?
Pravastatin is an investigational medicine, being studied as a potential treatment for lymphedema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- ECOG performance status ≤2 (Karnofsky ≥60%,)
You likely can't join 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...
See the full eligibility criteria
- 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
- 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.