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

NCT ID: NCT02159157

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Early Stage Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: PLACEBO_COMPARATOR

Exercise prescription

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary Chamberlin

Mary Chamberlin, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Chamberlin, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

D12030

Identifier Type: -

Identifier Source: org_study_id