Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

Обзор

The goals of this clinical trial are to learn 1. Determine the feasibility of a home-based exercise analog therapy using Transcutaneous Electrical Nerve Stimulation (TENS), 2. Determine the effects of exercise analog therapy on muscle mass, strength, and clinical outcomes, and 3. Determine the effects of exercise analog therapy on immune phenotype and inflammation response in patients undergoing radiation for head and neck squamous cell carcinoma (HNSCC). The main question it aims to answer are: Does an exercise regimen using an analog TENS unit during the course of cancer treatment for those with HNSCC improve muscle mass, strength, clinical outcomes and immune response compared to those that do not perform the exercise regimen during their cancer treatment? Researchers will compare outcomes of patients undergoing cancer treatment + TENS unit exercise to those being treated for their cancer with no exercise TENS unit. In the exercise arm, subjects will use the TENS unit for 30 minutes of exercise a day, 3 times a week for the extent of their cancer treatments. Weekly check-ins by phone or less frequently at scheduled in person visits. Participants will keep a log of their exercise sessions to make sure that the exercise occurs 3 times a week for 30 minutes each and note any reasons why a session may have been missed or time shortened. Both arms will have a blood draw at the beginning of their cancer treatment and approximately 4 weeks after the last cancer treatment (\~40mL). These samples will be tested for molecules that signal a higher or lower immune response with the addition of the exercise in one group compared to the cancer therapy only group.

Вмешательства

• Другое Exercise
  Perform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.

Первичные конечные точки

• Number of Patients that complete TENS unit exercise as recommended [Срок оценки: beginning of cancer treatment to 4 weeks after cancer treatment concludes]

Вторичные конечные точки (3)

• Body Mass Index (BMI)=Weight (kg)/Height (m)^2 [Срок оценки: Once at beginning of cancer treatment and once 4 weeks post-cancer treatment]
• Percent Fat/Water/Muscle Content of Body [Срок оценки: Once prior to cancer treatment and once 4 weeks post treatment]
• Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL) [Срок оценки: Beginning of cancer treatment to 4 weeks post-cancer treatment]

Критерии участия

Критерии включения

• Adult patients (18 years or older)
• Diagnosed with head and neck squamous cell carcinoma
• HPV negative
• Undergoing treatment at OLOL H\&N Center

Критерии исключения

• Any subject less than 18 years of age.
• Subjects who have HPV positive HNSCC
• Subjects who have a pacemaker or electronic implant

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06839014 · IRB#8333_Kansara Exer Therapy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗