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Taking AIM at Breast Cancer

Primary Purpose

Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARE
TARE
Home-Based Stretching
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Circuit-style aerobic and resistance Exercise(CARE)

Traditional Aerobic Resistance Exercise (TARE)

Home-Based Stretching

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

4-month CARE intervention on sarcopenic obesity.
sarcopenic obesity will be assessed via dual energy X-ray absorptiometry using a validated equation.

Full Information

First Posted
January 19, 2021
Last Updated
January 17, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04720209
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Keywords
Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circuit-style aerobic and resistance Exercise(CARE)
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional Aerobic Resistance Exercise (TARE)
Arm Type
Experimental
Arm Description
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
Arm Title
Home-Based Stretching
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
CARE
Intervention Description
CARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week on-site
Intervention Type
Other
Intervention Name(s)
TARE
Intervention Description
TARE is a 16- week, supervised AE and RE program consisting of three sessions per week on-site
Intervention Type
Other
Intervention Name(s)
Home-Based Stretching
Intervention Description
This group will perform a home-based program of the same stretches utilized in the CARE and TARE groups.
Primary Outcome Measure Information:
Title
Decrease in adipose tissue levels of inflammation.
Description
Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs)
Time Frame
16 Weeks
Title
Decrease in adipose tissue levels of inflammation.
Description
Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8
Time Frame
16 weeks
Title
Decrease in adipose tissue levels of inflammation.
Description
Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
4-month CARE intervention on sarcopenic obesity.
Description
sarcopenic obesity will be assessed via dual energy X-ray absorptiometry using a validated equation.
Time Frame
16 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina M Dieli-Conwright, PhD
Phone
(617) 582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Dieli-Conwright, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD
Phone
617-732-8695
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Taking AIM at Breast Cancer

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