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

Protocol # :
Breast Cancer
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Not Applicable
Disease Sites
Principal Investigator
Dieli-Conwright, Christina, Marie

Trial 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.

Eligibility Requirements

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

- 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