[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04724499":3,"trial-entities:NCT04724499":123,"trial-summary:NCT04724499":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":61,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":99,"locations":102,"central_contacts":112,"overall_officials":113,"references":117,"see_also_links":122},"NCT04724499","20-222","Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy","Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)","ACTIVE_NOT_RECRUITING","2027-04-01","2026-01","2026-08-18","2021-07-14","Dana-Farber Cancer Institute","OTHER",true,"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.\n\nThe names of the study interventions involved in this study are\u002Fis:\n\n* High-Intensity Interval Training (HIIT)","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)\n\nThis 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.\n\nParticipants will be randomly assigned to one of two groups:\n\n* Group A: High Intensity Interval Training (HIIT) for 16 weeks\n* Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends\n\nThe 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.\n\nParticipants will receive study treatment for 4 months and will be followed for 4 months.\n\nThe total time for participation in this study will be about 8 months.\n\nIt is expected that about 30 people will take part in this research study.\n\nThe American Institute for Cancer Research is supporting this research by providing funding for the study.",[19,20,21,22],"Breast Cancer","Chemotherapy Effect","Exercise Therapy","Cognitive Change",[19,20,21,22],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},30,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","High-Intensity Intervals Training","16 week exercise program with stationary bike.",[34],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Attention Control","16 week stretching program.",[38],[42,46,49,52,55,58],{"measure":43,"description":44,"timeFrame":45},"Executive Function and Attention","Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.","16 weeks",{"measure":47,"description":48,"timeFrame":45},"Executive Function-Global Cognition","Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.",{"measure":50,"description":51,"timeFrame":45},"Executive Function-Working Memory","Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test",{"measure":53,"description":54,"timeFrame":45},"Executive Function-Episodic Memory","Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test",{"measure":56,"description":57,"timeFrame":45},"Executive Function-Semantic Fluency","Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test",{"measure":59,"description":60,"timeFrame":45},"Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity","Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)",[62,65],{"measure":63,"description":64,"timeFrame":45},"Cardio Fitness-maximal aerobic capacity","Cardiorespiratory fitness will be measured through a VO2 max test",{"measure":66,"description":64,"timeFrame":45},"Cardio Fitness-maximal power output","FEMALE","18 Years",null,false,{"inclusion":72,"exclusion":86,"raw_text":98},[73,74,75,76,77,78,79,80,81,82,83,84,85],"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\u002Fweek","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.",[87,88,89,90,91,92,93,94,95,96,97],"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\u002Fweek","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\u002FDFCI 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.","Inclusion Criteria:\n\n* Written informed consent prior to any study-related procedures\n* Women newly diagnosed (Stage I-III) breast cancer.\n* Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease\n* 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.\n* Will receive (neo)adjuvant chemotherapy\n* Speak English\n* Able to provide physician clearance to participate in the exercise program\n* Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)\n* Have not experienced a weight reduction ≥10% within the past 6 months\n* Currently participate in less than 60 minutes of structured exercise\u002Fweek\n* Does not smoke (no smoking during previous 12 months)\n* 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)\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease\n* Patients with other active malignancies are ineligible for this study.\n* Patients with metastatic disease\n* Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies\n* Participates in more than 60 minutes of structured exercise\u002Fweek\n* Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise\n* Have a pacemaker or any implantable device that are not MRI safe; the BWH\u002FDFCI Standard MRI screening form\n* Is unable to travel to DFCI\n* Patients who are pregnant\n* Patients with claustrophobia\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":104,"city":105,"state":106,"zip":107,"country":108,"geoPoint":109},"Brigham and Women's Hospital","Boston","Massachusetts","02115","United States",{"lat":110,"lon":111},42.35843,-71.05977,[],[114],{"name":115,"affiliation":13,"role":116},"Christina Dieli-Conwright, MD","PRINCIPAL_INVESTIGATOR",[118],{"pmid":119,"type":120,"citation":121},"37027186","DERIVED","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\u002F39740.",[],{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a randomized controlled pilot study with 30 participants, comparing a High-Intensity Interval Training (HIIT) group to a stretching group.","completed","Improving Cognitive Function with Exercise in Breast Cancer Patients Undergoing Chemotherapy","This study is looking at whether a 16-week exercise program called High-Intensity Interval Training (HIIT) can help improve brain health and heart function in women with newly diagnosed breast cancer (Stage I-III) who are undergoing chemotherapy. You would be randomly assigned to either the HIIT group or a stretching program. The researchers want to see if HIIT can improve thinking skills like executive function (planning and decision-making) and attention, which will be measured at 16 weeks. This is a pilot study, meaning it's the first time this specific exercise is being tested in this setting. The study aims to enroll 30 women aged 18 and older.","Your executive function and attention will be measured at 16 weeks after starting the intervention.",106,"You would undergo screening, then participate in either a 16-week HIIT program or a 16-week stretching program. Procedures include MRI, blood tests, bone scans, fitness and strength assessments, and surveys at the start and follow-up visits.","Not stated in the trial record.",[],"v2"]