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Exercise Intervention for the Prevention of Obesity and Improvement of Movement in Stage I-III Breast Cancer Survivors

Trial Status: Active

This clinical trial studies the effect of an exercise intervention in preventing obesity and improving movement in stage I-III breast cancer survivors. A 16-week exercise program may help to decrease inflammation in the fat tissue.

Inclusion Criteria

  • Women newly diagnosed (stage I-III) breast cancer, 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 principal investigator (PI). Urine strips will be utilized over bloodwork for cost effectiveness. Urine tests will be distributed once before dual-energy X-ray absorptiometry (DEXA) scans
  • Are centrally obese with the following criteria (determined by study team at eligibility screening): Body mass index (BMI) > 30 kg/m^2 (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 inches (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 within the past 36 months
  • 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

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Christina Dieli-Conwright
Phone: 617-582-8321

PRIMARY OBJECTIVE:

I. To determine the effects of a 4-month circuit aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.

SECONDARY OBJECTIVE:

I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.

EXPLORATORY OBJECTIVE:

I. To determine the effects of a 4-month CARE intervention on physical fitness, cognition, and quality of life (QOL) measures.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive CARE intervention for 3 sessions per week (2 mandatory on-site and 1 with option to be completed on-site or at home) over 50 minute each for 16 weeks.

GROUP II: Patients receive traditional aerobic and resistance exercise (TARE) intervention for 3 sessions per week (2 mandatory on-site and 1 with option to be completed on-site or at home) for 16 weeks.

GROUP III: Patients complete stretching exercise consisting of one set of 3-4 static stretching exercises held for 30 seconds and performed 3 days per week for 16 weeks.

After completion of study, patients in Groups I and II are followed up for 8 months.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Christina Dieli-Conwright

  • Primary ID 20-172
  • Secondary IDs NCI-2021-01662
  • Clinicaltrials.gov ID NCT04720209