About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Prednisone
DrugGiven orally
Ajovy
DrugGiven by injection
Manual Therapy
Other interventionParticipants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks.
IOPI device
DeviceParticipants will complete resistance exercise 3 days a week at home over 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: