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)

ConditionsLymphedema Fibrosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%,)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Pravastatin
Drug
Given by PO
Pentoxifylline
Drug
Given by PO
Tocopherol
Drug
Given by PO

Treatment groups

295 Participants

are divided into 3 treatment groups

Group A: Group 1Experimental treatment 1 intervention

Group B: Group 2Experimental treatment 2 interventions

Group C: Group 3No intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

Apply now