Can steroids, a migraine drug, or tongue exercises save nerves after throat cancer treatment?
NCT ID NCT07832266
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
People treated with radiation for oropharyngeal cancer can later develop damage to cranial nerves, especially the nerve that controls the tongue. This trial tests four approaches to see if they are safe and practical: high-dose prednisone, the injectable drug fremanezumab, a home program of manual tongue exercises, and tongue exercises using a resistance device. The study enrolls 48 adults who have no signs of cancer but show early nerve changes on a muscle test. Researchers will track side effects and how well participants complete each strategy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Four strategies: prednisone, fremanezumab, manual tongue exercises, and device-assisted tongue exercises
- What this could lead to
- If one of these strategies works, doctors could offer a way to protect tongue and throat nerves in people treated with radiation for oropharyngeal cancer.
- What could go wrong
- This is a small Phase 1 feasibility trial, so it mainly checks whether the treatments are safe and doable, not whether they work. The results may not apply to all patients, and steroids and injections carry their own risks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 reason and because CGRP agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to treatment initiation and for the duration of study treatment and for 5 months after the last dose (covering \~5 half lives). (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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. 6. 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). 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Primary surgery for OPC 2. Documented XII nerve injury by tumor or other non-cancer treatment source 3. History of multiple head and neck cancers or central nervous system cancer 4. Uncontrolled diabetes 5. Uncontrolled hypertension (systolic \>160; diastolic \>90) 6. Known gastrointestinal ulcer 7. History of psychiatric illness/social situations that would limit compliance with study requirements; 8. Untreated or treatment refectory obstructive pharyngoesophageal stricture 9. Known history or diagnosis of bipolar disorder 10. Functionally limiting cardiac, pulmonary, or neuromuscular disease 11. 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) 12. Hospitalization for heart failure or known NYHA Class III-IV heart failure within the previous 6 months. 13. Known ventricular arrhythmia requiring recent intervention (cardioversion, ablation, or antiarrhythmic initiation within 3 months), or currently symptomatic atrial fibrillation not rate-controlled. 14. Current or planned tracheostomy or total laryngectomy 15. Platelet \<50,000/mcL 16. Known hypersensitivity to fremanezumab-vfrm or any excipients (L-histidine, Lhistidine hydrochloride monohydrate, sucrose, disodium EDTA, polysorbate 80, water for injection)37 17. History of serious hypersensitivity reaction to another CGRP monoclonal antibody (erenumab, galcanezumab, eptinezumab)46 18. Pregnant and breastfeeding women are excluded from this study because the safety of Ajovy during pregnancy has not been established. Human data are insufficient to assess fetal risk, and as a monoclonal antibody, Ajovy may cross the placenta. It is also unknown whether Ajovy is present in human milk or what effects it may have on a breastfed infant. These potential risks may also apply to other agents used in this study. Pregnancy or women actively planning pregnancy during the treatment period37 and those Breastfeeding during the treatment period46 19. Currently taking the following medications: Other CGRP antagonists (biologic or small molecule): erenumab (Aimovig®), galcanezumab (Emgality®), eptinezumab (Vyepti®), rimegepant (Nurtec®), ubrogepant (Ubrelvy®), atogepant (Qulipta®) 20. Current cognitive or other limitations that preclude independent completion of study regimen 21. Patients who are receiving any other investigational agents. 22. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ajovy®- Fremanezumab or other agents used in study. 23. Current corticosteroid therapy prior to enrollment 24. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT MD Anderson
Houston, Texas, 77030, United States
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