A Phase 1 interventional study of Prednisone and Ajovy in Cranial Nerve Injury and Oropharyngeal Cancer, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
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Among 26 studies in Oropharyngeal Neoplasms by M.D. Anderson Cancer Center — 4 open to participants now, 10 under way, 1 of them phase 3. Oropharyngeal Neoplasms · M.D. Anderson Cancer Center.
Among the 26 studies in Oropharyngeal Neoplasms by M.D. Anderson Cancer Center, this one is the 5th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2027, is the only one in phase 1, and was the 26th registered.
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
Browse Oropharyngeal Neoplasms studies →4 of the 26 studies in Oropharyngeal Neoplasms by M.D. Anderson Cancer Center are open now, in 1 country. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 89 Oropharyngeal Neoplasms studies recruiting now, 76 (85%) set no upper age limit and 5 (6%) stop at 75 or younger; none take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 2
First in 2002; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is close to the median of 52 across 265 interventional studies indexed under Oropharyngeal Neoplasms.
Median enrollment 25 across the 17 interventional studies, 370 across the 9 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
7 of the studies in Oropharyngeal Neoplasms by M.D. Anderson Cancer Center that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01266044Phase 3M.D. Anderson Cancer CenterControlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia | 2026-12-31 |
| NCT00498875M.D. Anderson Cancer CenterDepression and Adherence in Head and Neck Cancer | 2026-12-31 |
| NCT03224000M.D. Anderson Cancer CenterTrial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer | 2026-12-31 |
| NCT04874493M.D. Anderson Cancer CenterPatient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer | 2027-02-02 |
| NCT02253238M.D. Anderson Cancer CenterSensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients | 2027-04-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 26 studies in Oropharyngeal Neoplasms by M.D. Anderson Cancer Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 and men must agree to use adequate (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:
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 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A high dose corticosteroid therapy 3mg/kg prednisone (±10%) per oral x 5 days with a 2-week taper (± 4 days)
Drug: Prednisone
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.
Drug: Ajovy
Manual therapy completed 3 days weekly by the patient at home with 3 clinician directed training visits over 8 weeks.
Other: Manual Therapy
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.
Device: IOPI device
Given orally
Also known as: Deltasone, Sterapred, Rayos
Given by injection
Also known as: Fremanezumab
Participants will complete manual therapy 3 days a week at home with 3 clinician-directed visits over 8 weeks.
Participants will complete resistance exercise 3 days a week at home over 8 weeks.
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
Start is estimated for Mar 2027; primary completion for Sep 2030, 42 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prednisone · Fremanezumab