Breast Cancer Clinical Trial
Taking AIM at Breast Cancer
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.
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.
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 (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.
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
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
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There are 2 Locations for this study
Boston Massachusetts, 02115, United States More Info
Boston Massachusetts, 02215, United States More Info
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