Taking AIM at Breast Cancer
1 other identifier
interventional
102
1 country
2
Brief Summary
The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Aug 2021
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
August 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
September 23, 2025
September 1, 2025
5.1 years
January 19, 2021
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs)
16 Weeks
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
16 weeks
Decrease in adipose tissue levels of inflammation.
Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a
16 weeks
Secondary Outcomes (1)
4-month CARE intervention on sarcopenic obesity.
16 Weeks
Study Arms (3)
Circuit-style aerobic and resistance Exercise(CARE)
EXPERIMENTALThis research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months. -16 weeks of circuit-style aerobic and resistance exercise
Traditional Aerobic Resistance Exercise (TARE)
EXPERIMENTALThis research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months \- 16 weeks of traditional aerobic and resistance exercise
Home-Based Stretching
ACTIVE COMPARATORAttention Control for 16 weeks home-based stretching -structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion
Interventions
CARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week on-site
TARE is a 16- week, supervised AE and RE program consisting of three sessions per week on-site
This group will perform a home-based program of the same stretches utilized in the CARE and TARE groups.
Eligibility Criteria
You may qualify if:
- Women diagnosed with breast cancer (all stages excluding stage IV), low grade disease positive for estrogen and progesterone receptors
- 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 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. Patients must undergo a pregnancy test via urine strip that will be covered and provided by the PI. Urine strips will be utilized over bloodwork for cost effectiveness. Urine tests will be distributed once before DEXA scans.
- Are centrally obese with the following criteria\[57\] (determined by study team at eligibility screening): BMI \>30 kg/m2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat \>30% (estimated by bioelectrical impedance), and waist circumference \>35 in.
- Have undergone a lumpectomy or mastectomy.
- If cancer treatment included neoadjuvant or adjuvant chemotherapy and/or radiation therapy, participant must have received and completed treatment.
- Speak English
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease.
- Have not experienced a weight reduction ≥10% within the past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy, trastuzumab or pertuzumab if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- +2 more criteria
You may not qualify if:
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Is not centrally obese as defined above
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Participates in more than 60 minutes of structured exercise/week
- Is planning reconstructive surgery with flap repair during trial and follow-up period
- Currently smokes
- Is unable to travel to the exercise facilities
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina M Dieli-Conwright, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2021
First Posted
January 22, 2021
Study Start
August 13, 2021
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.