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Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer

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ClinicalTrials.gov Identifier: NCT03091842
Recruitment Status : Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Central Obesity Estrogen Receptor Positive Postmenopausal Progesterone Receptor Positive Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Behavioral: Exercise Intervention Other: Informational Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients 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: Patients undergo supervised traditional aerobic and resistance exercise (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: Patients 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 digital video disc (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.

After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (CARE program)
Patients 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.
Behavioral: Exercise Intervention
Undergo supervised CARE program

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (TARE program)
Patients 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.
Behavioral: Exercise Intervention
Undergo supervised TARE program

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Active Comparator: Group III (home-based stretching program)
Patients 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.
Behavioral: Exercise Intervention
Undergo home-based stretching program

Other: Informational Intervention
Receive instructional DVD and booklet of the flexibility exercises

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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 [ Time Frame: Up to 16 weeks ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: Up to 8 years ]
    Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).

  2. Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 8 years ]
    Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).

  3. 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 [ Time Frame: Up to 8 years ]
    A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model. Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing).

  4. Sarcopenic obesity assessed using dual energy X-ray absorptiometry [ Time Frame: Up to 8 months ]
    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.


Other Outcome Measures:
  1. Disease free survival (DFS) [ Time Frame: From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years ]
    Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group). Ancillary analyses will assess associations of inflammation measures with DFS. Results will be presented as hazard ratios, with 95% confidence intervals. Unadjusted and adjusted survival curves will be presented by treatment group.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091842


Contacts
Contact: Zeno Ashai 323-865-0463 zeno.ashai@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Christina Dieli-Conwright    323-442-2905      
Principal Investigator: Christina Dieli-Conwright         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christina Dieli-Conwright, PhD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03091842     History of Changes
Other Study ID Numbers: 1B-16-11
NCI-2017-00070 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1B-16-11 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Inflammation
Obesity, Abdominal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Obesity
Overnutrition
Nutrition Disorders