Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)

Part of paid clinical trials in Houston, Texas.

Sponsor: M.D. Anderson Cancer Center
Study ID: NCT07832266
Phase: PHASE1
Status: Not Yet Recruiting

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Conditions

Cranial Nerve Injury
Oropharyngeal Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Prednisone — DRUG
Given orally
Ajovy — DRUG
Given by injection
Manual Therapy — OTHER
Participants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks.
IOPI device — DEVICE
Participants will complete resistance exercise 3 days a week at home over 8 weeks.

Study Details

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.

Key Dates

First listed: Sep 21, 2026
Start date: Mar 1, 2027
Status verified: Sep 2026
Primary completion: Sep 30, 2030
Completion: Sep 30, 2032

Study Design

Enrollment: 48 participants (estimated)
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: High Dose Corticosteroid Therapy (Prednisone)
A high dose corticosteroid therapy 3mg/kg prednisone (±10%) per oral x 5 days with a 2-week taper (± 4 days)
Experimental: CGRP inhibitor Therapy (Ajovy-Fremanezumab)
675 mg Ajovy®- Fremanezumab (quarterly injection) targeting inhibition of CGRP-mediated sensory nerve signaling as a strategy to preserve cranial nerve function in the early injury phase.
Experimental: Manual Therapy Facilitated Lingual Exercise
Manual therapy completed 3 days weekly by the patient at home with 3 clinician directed training visits over 8 weeks.
Experimental: Device-Facilitated Lingual Exercise
Device-facilitated lingual home exercise program for tongue strength and endurance completed at home by patient with 3 days weekly with 3 clinician directed training visits over 8 weeks.