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

ConditionsFibrosis SyndromeLymphedemaHead &Amp; Neck CancerFibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prior history of head and neck cancer with no active disease.

Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)

Detectable CTC-AE G2+ lymphedema/fibrosis at >6 months post-radiotherapy.

No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.

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)

    Drug

    Given PO

  • Pentoxifylline

    Drug

    Given PO

  • ketoprofen

    Drug

    Given PO

  • Pirfenidoneone

    Drug

    Given PO

  • Standard of Care (SOC)

    Other intervention

    SOC

  • tocopherol

    Drug

    Given PO

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: Treatment with Pravastatin QDExperimental treatment 1 intervention
Group B: Treatment with Pentoxifylline TID + TocopherolExperimental treatment 2 interventions
Group C: Treatment with Ketoprofen TIDExperimental treatment 1 intervention
Group D: Treatment with Pirfenidone TIDExperimental treatment 1 intervention
Group E: Treatment with SoC (Control)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and adverse events

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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