Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)
2 other identifiers
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2027
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 21, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2032
September 21, 2026
September 1, 2026
3.6 years
September 18, 2026
September 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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) 6.0
Through study completion; an average of 1 year
Study Arms (4)
High Dose Corticosteroid Therapy (Prednisone)
EXPERIMENTALA high dose corticosteroid therapy 3mg/kg prednisone (±10%) per oral x 5 days with a 2-week taper (± 4 days)
CGRP inhibitor Therapy (Ajovy-Fremanezumab)
EXPERIMENTAL675 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.
Manual Therapy Facilitated Lingual Exercise
EXPERIMENTALManual therapy completed 3 days weekly by the patient at home with 3 clinician directed training visits over 8 weeks.
Device-Facilitated Lingual Exercise
EXPERIMENTALDevice-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.
Interventions
Given orally
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.
Eligibility Criteria
You may qualify if:
- Adult (≥18 years of age)
- 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
- EMG evidence of XII neuropathy with no/equivocal physical examination signs, referred to in the protocol as "early/subclinical" CN XII neuropathy
- Consent to parent cohort PA14-0947 for integrated longitudinal outcomes tracking in the OPC-SURVIVOR research program
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to treatment initiation and for the duration of study treatment and for 5 months after the last dose (covering \~5 half lives).
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- Primary surgery for OPC
- Documented XII nerve injury by tumor or other non-cancer treatment source
- History of multiple head and neck cancers or central nervous system cancer
- Uncontrolled diabetes
- Uncontrolled hypertension (systolic \>160; diastolic \>90)
- Known gastrointestinal ulcer
- History of psychiatric illness/social situations that would limit compliance with study requirements;
- Untreated or treatment refectory obstructive pharyngoesophageal stricture
- Known history or diagnosis of bipolar disorder
- Functionally limiting cardiac, pulmonary, or neuromuscular disease
- Recent acute coronary syndrome or stroke (within 3 months) or uncontrolled severe coronary artery disease with symptoms or coronary revascularization procedure (bypass surgery or stent within the last 3 months)
- Hospitalization for heart failure or known NYHA Class III-IV heart failure within the previous 6 months.
- Known ventricular arrhythmia requiring recent intervention (cardioversion, ablation, or antiarrhythmic initiation within 3 months), or currently symptomatic atrial fibrillation not rate-controlled.
- Current or planned tracheostomy or total laryngectomy
- Platelet \<50,000/mcL
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Hutcheson, BA,MS,PHD
UT MD Anderson
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2026
First Posted
September 21, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2032
Last Updated
September 21, 2026
Record last verified: 2026-09