Набор скоро начнётся NCT07548476

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Без фазы С лечением Metastatic Bladder Cancer Peripheral Neuropathy Advanced Urothelial Cancer Metastatic Urothelial Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Acupuncture, Exercise.
Кому может быть актуально: Состояния в реестре: Metastatic Bladder Cancer, Peripheral Neuropathy, Advanced Urothelial Cancer, Metastatic Urothelial Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)

Обзор

The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with metastatic bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro). The names of the two study groups in this research study are: * Acupuncture + Virtual Exercise (AVE) * Virtual Exercise Only (VE)

Подробное описание

CIPN is a side effect of some kinds of chemotherapy, and can lead to pain, numbness, tingling, swelling, or muscle weakness, primarily in the hands and feet and may persist for months or even years after chemotherapy ends.

Acupuncture involves using tiny needles to stimulate nerves and pathways in the body, and early research shows it might be helpful in reducing symptoms of CIPN.

Participants will be randomized in a 1:1 fashion into one of two study groups: AVE Arm: Acupuncture + Virtual Exercise or VE Arm: Virtual Exercise Only. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, questionnaires, sensory tests, cycling test, and physical performance tests.

Participation in this research study is expected to last about 12 weeks.

About 50 people will take part in this study.

Вмешательства

Процедура Acupuncture
Acupuncture treatment with licensed acupuncturist.
Поведенческое Exercise
Virtually supervised, technology-based aerobic and resistance exercise program. Exercise bike and resistance bands will be provided to participants. Exercise sessions will be via HIPAA-compliant, teleconference platform Zoom.

Первичные конечные точки

Neuropathic Pain Scale (NPS) Score Change from Baseline [Срок оценки: At 12 weeks]

Вторичные конечные точки (10)

Brief Pain Inventory-Short Form (BPI-SF) Score Change from Baseline [Срок оценки: Participants will complete BPI-SF survey at baseline, week 3, 6, 9 and 12.]
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx) Score Change from Baseline [Срок оценки: The FACT/GOG-Ntx will be completed at baseline, and weeks 3, 6, 9, and 12.]
Chemotherapy-Induced Peripheral Neuropathy-20 (CIPN-20) Score Change from Baseline [Срок оценки: CIPN-20 will be completed as baseline, week 6 and 12.]
Quantitative Sensory Testing (QST) Scores Change from Baseline [Срок оценки: QST will be completed at baseline and week 12 (PPT and CPM will be assessed at baseline only).]
Relative Dose Intensity (RDI) [Срок оценки: RDI calculated at 12 weeks.]
Treatment Delays Rate (TDR) [Срок оценки: Up to 12 weeks]
Treatment Related Adverse Event (AE) Rate [Срок оценки: Up to 12 weeks]
Early Discontinuation Rates (EDR) [Срок оценки: At 12 weeks]
Weekly Exercise Session Completion Rates [Срок оценки: Assessed weekly during the 12-week intervention.]
Program Retention Rate [Срок оценки: Assessed at 3, 6, and 12 weeks]

Критерии участия

Критерии включения

Age ≥ 18 years old
Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)
Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third cycle
Self-reported ability to walk for 6 minutes and/or 2 blocks
Deemed acceptable for exercise by their treating provider
Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise/week, as assessed by the Godin Leisure-Time Exercise Questionnaire
Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)
Referrals to physical therapy are allowed during the study if necessary; and
Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.
Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin

Критерии исключения

History of peripheral neuropathy prior to EV-Pembro initiation
Patients with a pacemaker or other electronically charged medical device; or
Participate in more than 60 minutes of moderate or vigorous structured exercise/week

Investigators will not include the following special populations: