Exercise program to reduce inflammation in breast cancer survivors

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

This study is testing if a 16-week exercise program can help breast cancer survivors lower inflammation and possibly reduce their risk of cancer coming back.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Dana-Farber Cancer Institute (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy, radiation
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT04720209 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of a 16-week exercise program designed for women who have completed treatment for breast cancer. The study will investigate whether circuit-style aerobic and resistance exercise, traditional aerobic and resistance exercise, or home-based stretching can decrease inflammation in fat tissue, which may help reduce the risk of cancer recurrence. Participants will be screened for eligibility and will undergo evaluations and follow-up visits throughout the 12-month study period. Approximately 300 individuals are expected to participate in this intervention.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old diagnosed with breast cancer stages I to III, who have completed their treatment and are centrally obese.

Not a fit: Patients with stage IV breast cancer or those who are not centrally obese may not receive benefit from this study.

Why it matters

Potential benefit: If successful, this program could help reduce inflammation and potentially lower the risk of breast cancer recurrence in survivors.

How similar studies have performed: Other studies have shown promising results in using exercise to improve health outcomes in cancer survivors, suggesting this approach may be effective.

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

Where this trial is running

Boston, Massachusetts and 1 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Christina M Dieli-Conwright, PhD — Dana-Farber Cancer Institute
• Study coordinator: Christina M Dieli-Conwright, PhD

Conditions Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III