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A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02159157
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Mary Chamberlin, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE June 9, 2014
Last Update Posted Date August 21, 2020
Study Start Date  ICMJE June 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Change in activity as measured by the Activity Log [ Time Frame: from baseline to week 32 ]
A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Received Dose Intensity of chemotherapy (RDI) [ Time Frame: 32 weeks ]
    The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment)
  • Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F [ Time Frame: baseline (Day -28 to 1), week 24, 32 weeks ]
    Fatigue as measured by the FACIT-F survey
  • Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin [ Time Frame: baseline (Day -28 to 1), 32 weeks ]
  • Change from Baseline (day -28 to day 1) C-reactive protein [ Time Frame: Baseline (day -28 to day 1) and week 32 ]
    levels of C- reactive protein
  • Change from Baseline (Day -28 to day 1) Fasting insulin [ Time Frame: Baseline (day -28 to day 1) and week 32 ]
    Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32
  • Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Resting heart rate from baseline (day -28 to day 1) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Waist-hip ratio from baseline (day -28 to day 1) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data [ Time Frame: weekly for 32 weeks ]
    Average steps per week for weeks 1-32
  • Measures how likely a person is to continue with exercise prescription. [ Time Frame: From baseline to Week 32 ]
    How the participant is feeling about the exercise.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Received Dose Intensity of chemotherapy (RDI) [ Time Frame: 32 weeks ]
    The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment)
  • Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F [ Time Frame: baseline (Day -28 to 1), week 24, 32 weeks ]
    Fatigue as measured by the FACIT-F survey
  • Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin [ Time Frame: baseline (Day -28 to 1), 32 weeks ]
  • Change from Baseline (day -28 to day 1) C-reactive protein [ Time Frame: Baseline (day -28 to day 1) and week 32 ]
    levels of C- reactive protein
  • Change from Baseline (Day -28 to day 1) Fasting insulin [ Time Frame: Baseline (day -28 to day 1) and week 32 ]
    Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32
  • Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Resting heart rate from baseline (day -28 to day 1) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in Waist-hip ratio from baseline (day -28 to day 1) [ Time Frame: baseline (day -28 to day 1) and week 32 ]
  • Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data [ Time Frame: weekly for 32 weeks ]
    Average steps per week for weeks 1-32
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
Official Title  ICMJE A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
Brief Summary This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.
Detailed Description This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Early Stage Breast Cancer
Intervention  ICMJE Behavioral: Exercise prescription
A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.
Study Arms  ICMJE
  • No Intervention: Arm A

    Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy.

    Phone calls designed to support the patient to maintain current activity level.

  • Placebo Comparator: Arm B

    Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy.

    Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week.

    Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription.

    Intervention: Behavioral: Exercise prescription
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2014)
120
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
  2. Patients must have recovered from prior surgery.
  3. Patients must be able to walk unassisted without oxygen
  4. Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
  5. Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
  6. Karnofsky performance status > or = to 80%.
  7. Previous or ongoing Physical therapy treatments are acceptable.
  8. Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
  9. Participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).

Exclusion Criteria:

  1. Patients less than 18 years of age.
  2. Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
  3. Patients who are oxygen dependent.
  4. Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
  5. Patients with a Karnofsky performance status of < 80%.
  6. Pregnant.
  7. Unable to read or write in English.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02159157
Other Study ID Numbers  ICMJE D12030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Chamberlin, Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Chamberlin, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP