NCT07832266尚未招募1 期
Proactively Intervening On Early Cranial Nerve Injury As A Delayed Sequela Of Oropharyngeal Cancer: A Randomized Feasibility Clinical Trial For Pro-Habilitation (proNERVE RCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
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)
干预措施: Prednisone (Drug)
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.
干预措施: Manual Therapy (Other)
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.
干预措施: IOPI device (Device)
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.
干预措施: Ajovy (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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