High-Intensity Interval Training for Cognitive Function in Breast Cancer Patients

(CLARITY Trial)

Overseen by Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Uncontrolled illness, Active malignancies, Metastatic disease, others

No Placebo Group

Trial Summary

What is the purpose of 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)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment High-Intensity Interval Training for Cognitive Function in Breast Cancer Patients?

Research suggests that high-intensity interval training (HIIT) can improve cognitive function in breast cancer patients by enhancing physical performance and cardiorespiratory fitness, which are linked to better attention, memory, and overall cognitive abilities. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) safe for breast cancer patients?

Research suggests that high-intensity interval training (HIIT) is generally safe for breast cancer patients, even those undergoing chemotherapy, and can improve fitness levels. However, as with any exercise program, it is important for patients to consult with their healthcare provider before starting HIIT to ensure it is appropriate for their individual health conditions. ^{1 4 6 7 8}

How does high-intensity interval training (HIIT) differ from other treatments for cognitive function in breast cancer patients?

High-intensity interval training (HIIT) is unique because it is a time-efficient exercise method that can improve cognitive function by increasing blood flow to the brain, potentially offering similar or better benefits compared to traditional aerobic exercises. Unlike medications, HIIT is a physical activity that can enhance brain health and cognitive abilities, making it a novel approach for cognitive rehabilitation. ^{9 10 11 12 13}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for women over 18 with early-stage breast cancer (Stage I-III) who will undergo chemotherapy, do less than an hour of exercise a week, don't smoke, and can travel to DFCI for assessments. They must not be pregnant or have lost significant weight recently, and if they can become pregnant, they need to use birth control and take a pregnancy test.

Inclusion Criteria

Can start a workout program with supervision.

Does not smoke (no smoking during previous 12 months)

Women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception prior to study entry and for six months following duration of study participation

Exclusion Criteria

I have a history of heart disease or heart failure.

Patients who are pregnant

You do more than 60 minutes of planned exercise each week.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either High-Intensity Interval Training (HIIT) or Attention Control for 16 weeks

16 weeks

3 weekly supervised exercise sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

4 month follow-up test, 3 MRIs over 9 months

Open-label extension (optional)

Participants in the Attention Control group may opt into the High-Intensity Interval Training (HIIT) program after the study ends

Treatment Details

Interventions

• Attention Control (Other)
• High-Intensity Interval Training (HIIT) (Behavioral Intervention)

Trial Overview The study is testing whether a 16-week program of High-Intensity Interval Training (HIIT) can improve brain health and heart function in women receiving chemotherapy for breast cancer. Participants are randomly assigned to either the HIIT program or an attention control group.

Participant Groups

Group I: High-Intensity Intervals Training Experimental Treatment 1 Intervention

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control Participants assigned to the exercise group (HIIT), will receive an exercise bike and have 3 weekly supervised exercise training sessions for four (4) months/16weeks. Participants can choose to participate in the exercise sessions at home via zoom or in clinic. Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post High-Intensity Intervals Training (HIIT) tests and four (4) month follow up test and receive 3 MRIs over the span of 9 months.

Group II: Attention Control Active Control 1 Intervention

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control Participants assigned to the Attention Control group, will receive instruction on a 16 week home-based stretching program. Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post home-based stretching program tests and receive 3 MRIs over the span of 9 months. At the end of the 16-week home-based stretching program, participants will be provided the option to participate in the High-Intensity Intervals Training (HIIT) program.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Findings from Research

This study will evaluate the effects of high-intensity interval endurance training (HIIT) on cancer-related cognitive impairments (CRCI) in 59 breast cancer patients undergoing chemotherapy, comparing it to a placebo intervention over a treatment period of 12-18 weeks.

The research aims to uncover not only the efficacy of HIIT in improving cognitive function but also the underlying immunological and neurobiological mechanisms, potentially providing a supportive therapy for cognitive decline in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the "Chemobrain in Motion - study" (CIM - study): a randomized placebo-controlled trial of the impact of a high-intensity interval endurance training on cancer related cognitive impairments in women with breast cancer receiving first-line chemotherapy. Oberste, M., Schaffrath, N., Schmidt, K., et al.[2023]

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) both improved aerobic capacity (VO2peak) and waist circumference in breast cancer survivors over a 12-week program, but there were no significant differences between the two training methods.

While HIIT led to increases in minute ventilation and peak workload, it did not result in a greater improvement in VO2peak compared to MICT, suggesting that both training intensities are beneficial for previously trained breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. Bell, RA., Baldi, JC., Jones, LM.[2021]

High-intensity interval training (HIIT) has been shown to significantly improve cardiorespiratory fitness in breast cancer survivors, based on a review of 13 randomized controlled trials.

All HIIT interventions were supervised and lab-based, indicating a need for further research into the feasibility and effectiveness of home-based or unsupervised HIIT programs for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. Tsuji, K., Matsuoka, YJ., Ochi, E.[2021]

A 12-week study involving 33 women at high risk for breast cancer found no significant differences in natural killer (NK) cell function or circulating myokines between high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT).

The results suggest that exercise intensity may not play a crucial role in enhancing NK cell function, but individuals with lower cardiorespiratory fitness may benefit more from structured exercise training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of high-intensity interval exercise training on NK-cell function and circulating myokines for breast cancer prevention among women at high risk for breast cancer. Coletta, AM., Agha, NH., Baker, FL., et al.[2021]

The EPICC Study is a randomized controlled trial involving 254 postmenopausal women with early-stage breast cancer, testing the impact of a six-month moderate-intensity aerobic exercise program on cognitive function during aromatase inhibitor therapy.

This study aims to address cognitive impairment, which affects up to 75% of breast cancer survivors, and if successful, could establish exercise as a low-cost, adaptable intervention to improve cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. Gentry, AL., Erickson, KI., Sereika, SM., et al.[2023]

High-intensity interval training (HIIT) is a feasible exercise strategy for breast cancer patients undergoing anthracycline-based chemotherapy, with 80% of participants attending the majority of sessions and completing an average of 78 minutes of exercise per week.

The HIIT intervention successfully maintained cardiorespiratory fitness (VO2max) in participants, while the control group experienced a significant decline in VO2max, highlighting the potential of HIIT to counteract the negative effects of chemotherapy on fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. Lee, K., Kang, I., Mack, WJ., et al.[2023]

Acute high intensity interval training (HIIT) and sprint interval training (SIT) have shown significant improvements in cognitive functions related to work performance, such as attention and memory, in 18 out of 36 studies reviewed, involving a total of 11 to 945 participants.

Despite the promising results, most studies were conducted in controlled environments rather than actual workplace settings, indicating a need for further research to explore the practical applications of HIIT/SIT on cognitive function in real-world job scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity and sprint interval training, and work-related cognitive function in adults: A systematic review. Gilson, ND., Andersson, D., Papinczak, ZE., et al.[2023]

In a study of 26 healthy young adults, high-intensity interval training (HIIT) significantly improved cognitive function, specifically executive function and semantic fluency, by 20% compared to moderate-intensity continuous training (MICT).

Both HIIT and MICT increased serum lactate levels, but there were no harmful changes in cerebrovascular circulation, indicating that HIIT is safe and beneficial for cognitive performance without adverse effects on brain blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle cerebral artery blood velocity and cognitive function after high- and moderate-intensity aerobic exercise sessions. Oliva, HNP., Oliveira, GM., Oliva, IO., et al.[2023]

In a study involving 69 young adults, both high-intensity functional training (HIFT) and moderate-intensity continuous training (MICT) significantly improved cognitive function, particularly in tasks measuring executive function and selective attention, as shown by faster response times and more correct answers on the Stroop Test.

No significant cognitive improvements were observed in the control group, indicating that both HIFT and MICT can positively influence cognitive performance immediately after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of High-Intensity Functional Training and Moderate-Intensity Continuous Training on Cognitive Functions in Young Adults. de Diego-Moreno, M., Álvarez-Salvago, F., Martínez-Amat, A., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Protocol for the "Chemobrain in Motion - study" (CIM - study): a randomized placebo-controlled trial of the impact of a high-intensity interval endurance training on cancer related cognitive impairments in women with breast cancer receiving first-line chemotherapy. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on functional performance and maximal oxygen uptake in comparison with moderate intensity continuous training in cancer patients: a systematic review and meta-analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Additional cardiovascular fitness when progressing from moderate- to high-intensity exercise training in previously trained breast cancer survivors. [2021]

4. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training in breast cancer survivors: a systematic review. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of high-intensity interval exercise training on NK-cell function and circulating myokines for breast cancer prevention among women at high risk for breast cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

High intensity and sprint interval training, and work-related cognitive function in adults: A systematic review. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Middle cerebral artery blood velocity and cognitive function after high- and moderate-intensity aerobic exercise sessions. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Interval Training on Executive Functions in College Students: Evidence from Different Doses. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Effects of High-Intensity Functional Training and Moderate-Intensity Continuous Training on Cognitive Functions in Young Adults. [2023]

13. China pubmed.ncbi.nlm.nih.gov

[Research advances on high-intensity interval training and cognitive function]. [2021]