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

NCT02159157 | Completed DMC

• 1 other identifier: D12030
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Breast Cancer

Keywords

breast cancer, exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Received Dose Intensity of chemotherapy (RDI)

  32 weeks

• Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F

  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

  Baseline (day -28 to day 1) and week 32

• Change from Baseline (Day -28 to day 1) Fasting insulin

  Baseline (day -28 to day 1) and week 32

Study Arms (2)

Arm A

NO INTERVENTION

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.

Arm B

PLACEBO COMPARATOR

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

Interventions

Exercise prescription BEHAVIORAL

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.

Arm B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
• Patients must have recovered from prior surgery.
• Patients must be able to walk unassisted without oxygen
• 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.
• Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
• Karnofsky performance status \> or = to 80%.
• Previous or ongoing Physical therapy treatments are acceptable.
• Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
• 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).

You may not qualify if:

• Patients less than 18 years of age.
• Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
• Patients who are oxygen dependent.
• Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
• Patients with a Karnofsky performance status of \< 80%.
• Pregnant.
• Unable to read or write in English.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Mary Chamberlin, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Chamberlin, MD

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: December 31, 2018
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)