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

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.

Study Overview

• Status: Completed
• Conditions: Early Stage Breast Cancer
• Intervention / Treatment: Behavioral: Exercise prescription

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activity as measured by the Activity Log	A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.	from baseline to week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Received Dose Intensity of chemotherapy (RDI)	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)	32 weeks
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F	Fatigue as measured by the FACIT-F survey	baseline (Day -28 to 1), week 24, 32 weeks
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin		baseline (Day -28 to 1), 32 weeks
Change from Baseline (day -28 to day 1) C-reactive protein	levels of C- reactive protein	Baseline (day -28 to day 1) and week 32
Change from Baseline (Day -28 to day 1) Fasting insulin	Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32	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)		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		baseline (day -28 to day 1) and week 32
Change in Resting heart rate from baseline (day -28 to day 1)		baseline (day -28 to day 1) and week 32
Change in Waist-hip ratio from baseline (day -28 to day 1)		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	Average steps per week for weeks 1-32	weekly for 32 weeks
Measures how likely a person is to continue with exercise prescription.	How the participant is feeling about the exercise.	From baseline to Week 32

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Mary Chamberlin, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer, exercise
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D12030