Taking AIM at Breast Cancer

Launched by DANA-FARBER CANCER INSTITUTE · Jan 19, 2021

Keywords

ClinConnect Summary

The "Taking AIM at Breast Cancer" trial is studying whether a 16-week exercise program can help reduce inflammation in fat tissue for women who have completed treatment for breast cancer, including surgery, chemotherapy, or radiation. This research is focused on women with early-stage breast cancer (stages I, II, and III) who are in remission and have specific health criteria, such as being centrally obese (with a certain body mass index or waist size) and currently not participating in regular exercise.

To participate, women must be over 18 years old, speak English, and agree to use birth control if they could become pregnant during the study. They should also be able to safely start a supervised exercise program without any serious health issues that could affect their ability to exercise. If you or someone you know meets these criteria and is interested in joining the study, they can expect to engage in a guided exercise routine at the Dana-Farber Cancer Institute, with the goal of improving their health after overcoming breast cancer.

Gender

FEMALE

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