Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03091842
Other study ID # 1B-16-11
Secondary ID NCI-2017-000701B
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 29, 2019
Est. completion date July 29, 2025

Study information

Verified date October 2019
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 29, 2025
Est. primary completion date July 29, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Exercise Intervention
Undergo supervised CARE program
Exercise Intervention
Undergo supervised TARE program
Exercise Intervention
Undergo home-based stretching program
Other:
Informational Intervention
Receive instructional DVD and booklet of the flexibility exercises
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Disease free survival (DFS) 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. From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
Primary 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 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) 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). Up to 8 years
Secondary Overall survival 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). From randomization to death from any cause, assessed up to 8 years
Secondary 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 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). Up to 8 years
Secondary Sarcopenic obesity assessed using dual energy X-ray absorptiometry 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 8 months
See also
  Status Clinical Trial Phase
Completed NCT02235051 - Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors N/A
Terminated NCT02454777 - High-Intensity Interval Training for Stage I-III Breast Cancer Patients N/A
Completed NCT03061175 - Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy N/A
Completed NCT01959490 - Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer Phase 2
Recruiting NCT03156309 - Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission Phase 1
Terminated NCT01368263 - Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer Phase 2
Completed NCT01928186 - FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer N/A
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00070252 - Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer Phase 1/Phase 2
Active, not recruiting NCT02780401 - Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission Phase 1
Completed NCT02728596 - S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) N/A
Completed NCT01478477 - Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole N/A
Completed NCT03364348 - 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Phase 1
Completed NCT02897375 - Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Phase 1
Withdrawn NCT01695057 - Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer N/A
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Completed NCT00416715 - Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer Phase 2