The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

Официальное название

The Effects of Acute and Chronic Exercise on the Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

Обзор

This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.

Подробное описание

PRIMARY OBJECTIVES:

I. Determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.

II. Determine how circulating immune cell mobilization and function (cell counts \& cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.

III. Evaluate the effectiveness of 12-weeks of semi-supervised exercise training (ET) versus (vs.) usual care (UC) at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent non-Hodgkin (NHL) lymphoma during or after treatment.

IV. Determine that extent to which 12-weeks of semi-supervised ET can modify circulating immune cell mobilization and immune function in individuals with indolent NHL during or after treatment compared to UC.

V. Development of a forward-chaining AI expert system using both manual and physiology derived feedback to optimize training results and compare its efficacy at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent NHL and CLL to that of the semi-supervised ET.

OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2. Patients with indolent NHL will be assigned to Aims 3 and 4.

AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing \[CPET\]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.

AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.

AIMS 3-4: Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6-minute walk test (6MWT). Patients are then randomized to 1 of 2 arms.

ARM I: Patients receive usual care on study.

ARM II: Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

AIM 5: All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

After completion of study intervention, patients are followed up every 6 months (Aims 2-4) or annually (Aim 5) for 3 years.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood
• Другое Cardiopulmonary Exercise Testing
  Undergo CPET
• Процедура Dual X-ray Absorptiometry
  Undergo DEXA scan
• Другое Electronic Health Record Review
  Ancillary studies
• Другое Exercise Intervention
  Undergo aerobic based training program
• Процедура Physical Examination
  Undergo measurement of height/weight and vital signs
• Другое Questionnaire Administration
  Ancillary studies
• Процедура Spirometry
  Undergo spirometry
• Другое Physical Performance Testing
  Undergo muscular strength and functional endurance measurements
• Другое Best Practice
  Receive usual care

Первичные конечные точки

• Assess circulating immune cell abundance and function pre-intervention [Срок оценки: Baseline]
• Assess circulating immune cell mobilization and function post-intervention [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• English speaking
• Between the ages of 18-80
• Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study

Критерии исключения

• Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease \[COPD\], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
• Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT05876923 · 22-012246 · NCI-2023-03210 · 22-012246

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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