Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy

Официальное название

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)

Обзор

The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function. The names of the study interventions involved in this study are/is: * High-Intensity Interval Training (HIIT)

Подробное описание

This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant)

This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer.

Participants will be randomly assigned to one of two groups:

* Group A: High Intensity Interval Training (HIIT) for 16 weeks * Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends

The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits.

Participants will receive study treatment for 4 months and will be followed for 4 months.

The total time for participation in this study will be about 8 months.

It is expected that about 30 people will take part in this research study.

The American Institute for Cancer Research is supporting this research by providing funding for the study.

Вмешательства

• Поведенческое High-Intensity Intervals Training
  16 week exercise program with stationary bike.
• Другое Attention Control
  16 week stretching program.

Первичные конечные точки

• Executive Function and Attention [Срок оценки: 16 weeks]
• Executive Function-Global Cognition [Срок оценки: 16 weeks]
• Executive Function-Working Memory [Срок оценки: 16 weeks]
• Executive Function-Episodic Memory [Срок оценки: 16 weeks]
• Executive Function-Semantic Fluency [Срок оценки: 16 weeks]
• Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity [Срок оценки: 16 weeks]

Вторичные конечные точки (2)

• Cardio Fitness-maximal aerobic capacity [Срок оценки: 16 weeks]
• Cardio Fitness-maximal power output [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• Written informed consent prior to any study-related procedures
• Women newly diagnosed (Stage I-III) breast cancer.
• Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
• The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
• Will receive (neo)adjuvant chemotherapy
• Speak English
• Able to provide physician clearance to participate in the exercise program
• Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
• Have not experienced a weight reduction ≥10% within the past 6 months
• Currently participate in less than 60 minutes of structured exercise/week
• Does not smoke (no smoking during previous 12 months)
• Willing to travel to DFCI for assessments (54 visits total for those who elect the exercise group with on campus training session, 6 visits for those that elect the exercise at home option, 6 visits for those assigned to the control group)
• Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
• Patients with other active malignancies are ineligible for this study.
• Patients with metastatic disease
• Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
• Participates in more than 60 minutes of structured exercise/week
• Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
• Have a pacemaker or any implantable device that are not MRI safe; the BWH/DFCI Standard MRI screening form
• Is unable to travel to DFCI
• Patients who are pregnant
• Patients with claustrophobia
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

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

• Brigham and Women's Hospital — Boston

Публикации

• Wilson R, Kang DW, Tahbaz M, Norris M, Uno H, Ligibel J, Guenette J, Christopher C, Dieli-Conwright C. Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 7;12:e39740. doi: 10.2196/39740. PMID 37027186

Идентификаторы

NCT: NCT04724499 · 20-222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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