ACTIVE_NOT_RECRUITING

Taking AIM at Breast Cancer

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-13

Study Completion:2026-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04720209

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Christina M Dieli-Conwright, PhD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Christina M Dieli-Conwright, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-08-13

Study Completion Date2026-09-15

Study Record Updates

Study Start Date2021-08-13

Study Completion Date2026-09-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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