Cranial Nerve InjuryPhase 1NCT07832266
Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)
A Phase 1 study testing Prednisone, Ajovy and Manual Therapy in people with Cranial Nerve Injury and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Nerve Injury, Oropharyngeal Cancer
- What is being tested?
- Prednisone, Ajovy and Manual Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Sep 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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).
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- 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.
Who cannot join
- 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
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- 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
- Known hypersensitivity to fremanezumab-vfrm or any excipients (L-histidine, Lhistidine hydrochloride monohydrate, sucrose, disodium EDTA, polysorbate 80, water for injection)37
- History of serious hypersensitivity reaction to another CGRP monoclonal antibody (erenumab, galcanezumab, eptinezumab)46
- 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
- Currently taking the following medications: Other CGRP antagonists (biologic or small molecule): erenumab (Aimovig®), galcanezumab (Emgality®), eptinezumab (Vyepti®), rimegepant (Nurtec®), ubrogepant (Ubrelvy®), atogepant (Qulipta®)
- Current cognitive or other limitations that preclude independent completion of study regimen
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ajovy®- Fremanezumab or other agents used in study.
- Current corticosteroid therapy prior to enrollment
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Katherine Hutcheson, BA,MS,PHD, 713-792-6513, karnold@mdanderson.org
Katherine Hutcheson, BA,MS,PHD
About this study
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.
Read the detailed description
Primary Objective:
To examine the feasibility of high dose steroid therapy, CGRP inhibitor therapy (Ajovy) or behavioral therapies for early/subclinical XII neuropathy after oropharyngeal radiation.
Secondary Objective:
To estimate acceptability and achievable effect sizes for each intervention strategy.
Exploratory Objective:
To explore potential for functional preservation and mechanisms of action for each intervention strategy.
- Conditions
- Cranial Nerve Injury, Oropharyngeal Cancer
- Being tested
- Prednisone, Ajovy, Manual Therapy, IOPI device
- Medical subject headings
- Cranial Nerve Injuries, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Deltasone, Sterapred, Rayos
Given orally
AjovyDrug
Also called Fremanezumab
Given by injection
Manual TherapyOther
Participants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks.
IOPI deviceDevice
Participants will complete resistance exercise 3 days a week at home over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Corticosteroid Therapy (Prednisone) | Experimental | A high dose corticosteroid therapy 3mg/kg prednisone (±10%) per oral x 5 days with a 2-week taper (± 4 days) Receives: Drug: Prednisone |
| CGRP inhibitor Therapy (Ajovy-Fremanezumab) | Experimental | 675 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. Receives: Drug: Ajovy |
| Manual Therapy Facilitated Lingual Exercise | Experimental | Manual therapy completed 3 days weekly by the patient at home with 3 clinician directed training visits over 8 weeks. Receives: Other: Manual Therapy |
| Device-Facilitated Lingual Exercise | Experimental | Device-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. Receives: Device: IOPI device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Nerve InjuryStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Hutcheson, BA,MS,PHD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832266
- Sponsor's protocol ID
- 2026-0063
- Other IDs
- NCI-2026-06933
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)
- ClinicalTrials.gov ID
- NCT07832266
- Acronym / sponsor ID
- 2026-0063
- Conditions
- Cranial Nerve Injury, Oropharyngeal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
To examine the feasibility of high dose steroid therapy, CGRP inhibitor therapy (Ajovy) or behavioral therapies for early/subclinical XII neuropathy after oropharyngeal radiation.
Secondary Objective:
To estimate acceptability and achievable effect sizes for each intervention strategy.
Exploratory Objective:
To explore potential for functional preservation and mechanisms of action for each intervention strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Dose Corticosteroid Therapy (Prednisone) | Experimental | Drug: PrednisoneA 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) | Experimental | Drug: Ajovy675 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 | Experimental | Other: Manual TherapyManual therapy completed 3 days weekly by the patient at home with 3 clinician directed training visits over 8 weeks. |
| Device-Facilitated Lingual Exercise | Experimental | Device: IOPI deviceDevice-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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:
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: Deltasone, Sterapred, RayosGiven orally | Drug | High Dose Corticosteroid Therapy (Prednisone) |
| AjovyAlso: FremanezumabGiven by injection | Drug | CGRP inhibitor Therapy (Ajovy-Fremanezumab) |
| Manual TherapyParticipants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks. | Other | Manual Therapy Facilitated Lingual Exercise |
| IOPI deviceParticipants will complete resistance exercise 3 days a week at home over 8 weeks. | Device | Device-Facilitated Lingual Exercise |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Hutcheson, BA,MS,PHD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prednisone, Ajovy and Manual Therapy in people with Cranial Nerve Injury and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Hutcheson, BA,MS,PHD ((713) 792-6513, karnold@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.