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

(CLARITY Trial)

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 16-week high-intensity interval training (HIIT) exercise program can improve brain health and heart function in women undergoing chemotherapy for breast cancer. Participants will be randomly assigned to either a HIIT exercise group or a stretching and relaxation group. Women newly diagnosed with stage I-III breast cancer and receiving chemotherapy might be suitable candidates, particularly if they exercise less than one hour per week and do not smoke. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance quality of life during cancer treatment.

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 prior data suggests that High-Intensity Interval Training (HIIT) is safe for breast cancer patients undergoing chemotherapy?

Research has shown that high-intensity interval training (HIIT) is generally safe for breast cancer patients. A review of 35 studies with 1,893 participants found that HIIT led to significant physical improvements, suggesting it is relatively safe for those undergoing cancer treatments. Many participants adhere to the HIIT program, with compliance rates between 57% and 83%, indicating it is manageable for most. Additionally, HIIT is linked to a roughly 20% lower risk of cancer recurrence and a reduced risk of death, enhancing its safety profile. While more research is needed, these findings support the potential safety and benefits of HIIT in breast cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using High-Intensity Interval Training (HIIT) for cognitive function in breast cancer patients because it offers a non-pharmacological approach to improving brain health. Unlike traditional treatments like medication or cognitive therapy, HIIT involves short bursts of intense exercise that can be done at home or in a clinic, making it more accessible and flexible. This method has the potential to enhance cognitive function by promoting better blood flow and brain plasticity, which are crucial for maintaining mental sharpness. Additionally, the exercise-based approach may also improve overall physical health, offering a holistic benefit that goes beyond cognitive improvement.

What evidence suggests that this trial's treatments could be effective for improving cognitive function in breast cancer patients?

Research has shown that High-Intensity Interval Training (HIIT), which participants in this trial may receive, can benefit breast cancer patients undergoing chemotherapy. Studies have found that HIIT improves heart and lung fitness and strengthens muscles. It might also reduce fatigue and emotional issues, common during chemotherapy. Early results suggest that HIIT could enhance brain health in breast cancer patients. Overall, HIIT offers a quick way to improve physical fitness and may enhance quality of life during treatment. Meanwhile, participants in the Attention Control group will engage in a home-based stretching program, serving as an active comparator in this trial. ^{1 3 6 7 8}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• High-Intensity Interval Training (HIIT)

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.

How Is the Trial Designed?

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+

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Published Research Related to This Trial

High-intensity interval training (HIIT) is an efficient exercise strategy that can provide similar or even superior health benefits compared to traditional aerobic exercise, making it a time-saving option for improving overall health.

Recent studies suggest that HIIT may be particularly effective in enhancing cognitive function and could serve as a rehabilitation therapy for cognitive impairments related to obesity, diabetes, stroke, and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research advances on high-intensity interval training and cognitive function]. Hu, JY., Cai, M., Shang, QH., 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]

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]

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]

High-intensity interval training (HIIT) significantly improves functional performance in cancer patients, with notable increases in walking distance and mobility, as well as a 10.68% improvement in relative peak oxygen uptake (relV̇O2PEAK) compared to moderate intensity continuous training (MICT) which showed a 7.4% improvement.

The study included 31 trials with 1555 cancer patients, indicating that HIIT may be more effective than MICT for enhancing relV̇O2PEAK, suggesting that HIIT could be a preferred training method for improving physical performance in this population.

NCBI (Pubmed)

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. Neuendorf, T., Haase, R., Schroeder, S., 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]

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]

Both low-dose and moderate-dose high-intensity interval training (HIIT) improved executive functions (EF) in college students after 6 weeks, with moderate-dose HIIT showing greater benefits.

After 12 weeks, while both HIIT groups experienced a decline in EF, the moderate-dose group still demonstrated superior performance compared to the low-dose group, suggesting that moderate-dose HIIT is more effective for enhancing cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Interval Training on Executive Functions in College Students: Evidence from Different Doses. Wang, X., Liu, Z., Zhang, H., 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]

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]

In a study of 73 postmenopausal women with early-stage breast cancer, higher levels of physical activity were linked to improved cognitive functions such as attention, visual memory, and psychomotor speed.

Better cardiorespiratory fitness, measured by peak maximum VO2, was associated with enhanced concentration, verbal memory, and working memory, suggesting that both physical activity and fitness may positively impact cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer. Bender, CM., Sereika, SM., Gentry, AL., 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]

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