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

Recruiting Phase 2 Interventional Study
Fibrosis Syndrome Lymphedema Head &Amp; Neck Cancer Fibrosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
250 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
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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.

Trial Locations
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Eligibility Criteria
Eligibility Criteria Eligibility criteria (observational registry or randomization) 1. Prior history of head and neck cancer with no active disease. 2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s) 3. Detectable CTC-AE G2+ ly…
Contacts

Clifton Fuller, MD

(832) 817-8568

cdfuller@mdanderson.org

CONTACT