LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients

Официальное название

LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients

Обзор

The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.

Подробное описание

This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.

Вмешательства

• Другое "Just Move" Exercise
  Subjects complete "Just Move" Exercises Five Times Per Week
• Другое Standard of Care Exercise
  Subjects exercise/move as tolerated

Первичные конечные точки

• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [Срок оценки: 18 month period]
• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [Срок оценки: 18 month period]

Вторичные конечные точки (4)

• Adverse Event Rate [Срок оценки: up to 18 months]
• Quality of Life measured by the PedsQL Cancer Module [Срок оценки: up to 18 months]
• Subject adherence to exercise regimen [Срок оценки: up to 18 months]
• Adverse Events Related to Exercise Program [Срок оценки: up to 18 months]

Критерии участия

Критерии включения

• Ages 2-25 at time of consent
• Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles
• Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
• As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study
• Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment.
• Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic.
• Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment.
• Not participating in another clinical trial that precludes participating in additional nondrug clinical trials.

Критерии исключения

• Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
• Any other uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements or would be considered unsafe for the child to participate as determined by the Investigator.
• Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
• Primary CNS Tumor
• Osteosarcoma

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Levine Children's Hospital — Charlotte

Идентификаторы

NCT: NCT05058508 · IRB00082746 · LCI-PED-NOS-EXER-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗