NCT04720209Active, not recruiting
Taking AIM at Breast Cancer
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 19 Jan 2021
- Start date
- 13 Aug 2021
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Dana-Farber Cancer Institute
- NCT number
- NCT04720209
What you commit to
- Study type: Interventional
- Participants enrolled: 102
- From 13 Aug 2021 to the primary completion date, 31 Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- Is planning reconstructive surgery with flap repair during trial and follow-up period
Other illness
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
Other
- Is not centrally obese as defined above
- Participates in more than 60 minutes of structured exercise/week
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.