Taking AIM at Breast Cancer

• ClinicalTrials.gov Identifier: NCT04720209
• Recruitment Status: Recruiting
• First Posted: January 22, 2021
• Last Update Posted: January 23, 2024
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: January 19, 2021
• First Posted Date: January 22, 2021
• Last Update Posted Date: January 23, 2024
• Actual Study Start Date: August 13, 2021
• Estimated Primary Completion Date: June 15, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2021)

• Decrease in adipose tissue levels of inflammation. [ Time Frame: 16 Weeks ]
  Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs)
• Decrease in adipose tissue levels of inflammation. [ Time Frame: 16 weeks ]
  Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
• Decrease in adipose tissue levels of inflammation. [ Time Frame: 16 weeks ]
  Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a

Original Primary Outcome Measures (submitted: January 19, 2021)

Decrease in adipose tissue levels of inflammation. [ Time Frame: 16 Weeks ]

Adipose tissue inflammation will be assessed by measuring: M1, M2, ATMs, and adipose tissue secretion levels of inflammatory cytokines secreted. Measuring blood biomarkers related to WAT inflammation will assess systemic inflammation: leptin, adiponectin, TNF-a, IL6, IL-8, hsCR

Current Secondary Outcome Measures (submitted: January 19, 2021)

4-month CARE intervention on sarcopenic obesity. [ Time Frame: 16 Weeks ]

sarcopenic obesity will be assessed via dual energy X-ray absorptiometry using a validated equation.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Taking AIM at Breast Cancer
• Official Title: Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
• 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.

Detailed Description

This study is about using different types of exercise to reduce inflammation in fat tissue in an effort to minimize the risk of cancer recurrence related to being overweight or obese. The investigators hope to learn whether participating in a specific exercise program can cause inflammation in the fat tissue to decrease.

The names of the study interventions involved in this study are:

• Circuit-style aerobic and resistance exercise (CARE)
• Traditional aerobic and resistance exercise (TARE)

The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits.

The study treatment will be for 4 months and participants will followed for 8 months.

The total time for participation in this study will be about 12 months. It is expected that about 300 people will take part in this research study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Breast Cancer
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III

Intervention

• Other: CARE
  CARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week on-site
• Other: TARE
  TARE is a 16- week, supervised AE and RE program consisting of three sessions per week on-site
• Other: Home-Based Stretching
  This group will perform a home-based program of the same stretches utilized in the CARE and TARE groups.

Study Arms

• Experimental: Circuit-style aerobic and resistance Exercise(CARE)

  This 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

  Intervention: Other: CARE
• Experimental: Traditional Aerobic Resistance Exercise (TARE)

  This 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

  Intervention: Other: TARE
• Active Comparator: Home-Based Stretching

  Attention 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

  Intervention: Other: Home-Based Stretching

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 19, 2021): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2026
• Estimated Primary Completion Date: June 15, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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)
• Willing to travel to Dana-Farber Cancer Institute
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christina M Dieli-Conwright, PhD; (617) 582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04720209
• Other Study ID Numbers: 20-172
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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

• Current Responsible Party: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Christina M Dieli-Conwright, PhD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: January 2024