M.D. Anderson Cancer Center
The goal of this clinical research study is to learn about possible intervention strategies to help control cranial neuropathy in patients after they receive radiation therapy for OPC. Four (4) strategies will be tested in this study: 1) high-dose corticosteroid therapy, 2) treatment with fremanezumab, 3) manual tongue exercise therapy, and 4) device-assisted tongue exercise therapy.
Primary Objective: To examine the feasibility of high dose steroid therapy, CGRP inhibitor therapy (Ajovy) or behavioral therapies for early/subclinical XII neuropathy after oropharyngeal radiation. Secondary Objective: To estimate acceptability and achievable effect sizes for each intervention strategy. Exploratory Objective: To explore potential for functional preservation and mechanisms of action for each intervention strategy.
Inclusion Criteria: 1. Adult (≥18 years of age) 2. Disease-free cancer survivors evaluated at UT MD Anderson after treatment of squamous cell carcinoma (SCCA) of the oropharynx or HPV/p16+ SCCA of the head and neck of unknown primary 3. EMG evidence of XII neuropathy with no/equivocal physical examination signs, referred to in the protocol as "early/subclinical" CN XII neuropathy 4. Consent to parent cohort PA14-0947 for integrated longitudinal outcomes tracking in the OPC-SURVIVOR research program 5. The effects of Ajovy®- Fremanezumab on the developing human fetus are unknown. For this reas…
Given orally
Given by injection
Participants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks.
Participants will complete resistance exercise 3 days a week at home over 8 weeks.
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