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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Prednisone

    Drug

    Given orally

  • Ajovy

    Drug

    Given by injection

  • Manual Therapy

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: High Dose Corticosteroid Therapy (Prednisone)Experimental treatment 1 intervention
Group B: CGRP inhibitor Therapy (Ajovy-Fremanezumab)Experimental treatment 1 intervention
Group C: Manual Therapy Facilitated Lingual ExerciseExperimental treatment 1 intervention
Group D: Device-Facilitated Lingual ExerciseExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: