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

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.

What this study is about