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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Intensity Intervals Training

    Behavioral

    16 week exercise program with stationary bike.

  • Attention Control

    Other intervention

    16 week stretching program.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-Intensity Intervals TrainingExperimental treatment 1 intervention
Group B: Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Executive Function and Attention

Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.

Time frame
16 weeks
2

Executive Function-Global Cognition

Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.

Time frame
16 weeks
3

Executive Function-Working Memory

Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test

Time frame
16 weeks
4

Executive Function-Episodic Memory

Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test

Time frame
16 weeks

Secondary outcomes

1

Cardio Fitness-maximal aerobic capacity

Cardiorespiratory fitness will be measured through a VO2 max test

Time frame
16 weeks
2

Cardio Fitness-maximal power output

Cardiorespiratory fitness will be measured through a VO2 max test

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

American Institute for Cancer Research

Collaborator