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Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedStudy Start
First participant enrolled
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2025
CompletedOctober 24, 2019
October 1, 2019
5 years
March 21, 2017
October 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted
Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.
Up to 16 weeks
Secondary Outcomes (4)
Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer)
Up to 8 years
Overall survival
From randomization to death from any cause, assessed up to 8 years
Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer
Up to 8 years
Sarcopenic obesity assessed using dual energy X-ray absorptiometry
Up to 8 months
Other Outcomes (1)
Disease free survival (DFS)
From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
Study Arms (3)
Group I (CARE program)
EXPERIMENTALPatients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
Group II (TARE program)
EXPERIMENTALPatients undergo supervised TARE program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
Group III (home-based stretching program)
ACTIVE COMPARATORPatients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional DVD and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
Interventions
Receive instructional DVD and booklet of the flexibility exercises
Correlative studies
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Postmenopausal (at time of diagnosis; including artificial menopause induced by previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade disease positive for estrogen and progesterone receptors
- 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
- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months
- Speak English or Spanish
- 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 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 if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC)
You may not qualify if:
- Patients with metastatic disease
- Is not centrally obese
- 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 facility at USC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Related Publications (1)
Kang DW, Wilson RL, Gonzalo-Encabo P, Norris MK, Hans M, Tahbaz M, Dawson J, Nguyen D, Normann AJ, Yunker AG, Sami N, Uno H, Ligibel JA, Mittelman SD, Dieli-Conwright CM. Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors (The AIM Trial): Rationale, Design, and Methods. Front Oncol. 2022 Jun 20;12:896995. doi: 10.3389/fonc.2022.896995. eCollection 2022.
PMID: 35795051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, PhD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2017
First Posted
March 27, 2017
Study Start
July 29, 2019
Primary Completion
July 29, 2024
Study Completion
July 29, 2025
Last Updated
October 24, 2019
Record last verified: 2019-10