Taking AIM at Breast Cancer

January 22, 2024 updated by: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
16 Weeks
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
16 weeks
Decrease in adipose tissue levels of inflammation.
Time Frame: 16 weeks
Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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