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Exercise Timing in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Timing Groups
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Exercise, Resistance Training, Aerobic Exercise, Exercise Time-of-Day, Breast Cancer, Breast Cancer Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Stage I-III Breast Cancer patients with plans to start chemotherapy or just started chemotherapy. Just started chemotherapy is defined as already receiving one cycle of chemotherapy. ECOG 0, 1, 2 Exclusion Criteria: Stage IV Breast cancer patients ECOG >/= 3 Stage I-III Breast Cancer patients who do not have plans to start chemotherapy or who have received more than one cycle of breast cancer chemotherapy.

Sites / Locations

  • Huntsman Cancer Institute at the University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Morning Group

Evening Group

Arm Description

Participants must start their exercise between the hours of 5am and 10am.

Participants must start their exercise between the hours of 3pm and 8pm.

Outcomes

Primary Outcome Measures

Feasibility of the intervention
The proportion of patients who complete at least 75% of their assigned workouts within the time-of-day window assigned throughout the four-week assessment period

Secondary Outcome Measures

Acceptability
Study acceptability will be measured as the proportion of patients who qualitatively report a positive response to at least half of exit survey themes.
Whole body physical function
Timed up and go test
Lower body physical function
30-second chair stand test
Whole body strength
Handgrip strength test
Cardiorespiratory fitness
Cardiorespiratory fitness test

Full Information

First Posted
March 21, 2023
Last Updated
July 7, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05821244
Brief Title
Exercise Timing in Breast Cancer Patients
Official Title
Feasibility of Manipulating Exercise Timing in Breast Cancer Survivors on Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the feasibility of assigning breast cancer survivors currently receiving chemotherapy to exercise at a specific time of day, e.g., morning or afternoon/evening, for a 4-week exercise intervention. Information gathered from this study will help inform a future, larger trial. Study Aims: 1. Assess the feasibility of engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Assigning windows of time within the day to complete exercise (e.g. 5-10am exercise start time vs. 3-8pm exercise start time) will be feasible among this patient population. 1a. Determine the acceptability engaging in exercise at an assigned time-of-day (e.g., morning or afternoon/evening) in breast cancer survivors on chemotherapy. Hypothesis: Engaging in exercise at an assigned time-of-day will be acceptable in this patient population. 2. To generate evidence on the magnitude of the effect sizes and outcome variability of physical function and human performance variables. Tests to be conducted at baseline and end of study to measure physical function and human performance variables include: Timed up and go test, 30-second chair stand, handgrip strength, cardiorespiratory fitness.
Detailed Description
Participants will be randomized 1:1 to an exercise timing group (AM or PM), of which they will be required to complete their exercise during a specific time of day. Participants randomized to the AM group will be required to start their exercise between 5am and 10am for the duration of the 4-week intervention. Participants randomized to the PM group will be required to start their exercise between 3pm and 8pm. At baseline and end of study assessments, participants will complete the following physical tests to evaluate physical function, strength, and cardiorespiratory fitness: timed up and go test, 30-second chair stand test, handgrip strength test, cardiorespiratory fitness test. These tests and assessments will be carried out with the Huntsman Cancer Institute (HCI) Wellness Center's Personal Optimism With Exercise Recovery (POWER) program. These tests will occur at the HCI Wellness Center gym. At the end of study assessments participants will also be asked to complete an exit survey, and two short questionnaires related to sleeping and eating habits. Participants will complete two personalized resistance exercise training sessions supervised by a Cancer Exercise Specialist via the telehealth platform in the electronic medical record. These resistance training sessions are part of the POWER program. Participants will also be required to engage in weekly, moderate-intensity aerobic exercise, with the goal of completing 90 minutes of aerobic exercise per week. The type of aerobic exercise engaged in (e.g., walking, biking, hiking, etc), and location to complete the aerobic exercise (e.g., at home, local park, local gym, HCI Wellness Center gym, etc.) is the participant's choice. Participant's will be required to submit weekly aerobic exercise training logs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Exercise, Resistance Training, Aerobic Exercise, Exercise Time-of-Day, Breast Cancer, Breast Cancer Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morning Group
Arm Type
Experimental
Arm Description
Participants must start their exercise between the hours of 5am and 10am.
Arm Title
Evening Group
Arm Type
Experimental
Arm Description
Participants must start their exercise between the hours of 3pm and 8pm.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Timing Groups
Intervention Description
Individualized resistance training program, consisting of twice weekly training sessions supervised via telehealth with a cancer exercise trainer.
Primary Outcome Measure Information:
Title
Feasibility of the intervention
Description
The proportion of patients who complete at least 75% of their assigned workouts within the time-of-day window assigned throughout the four-week assessment period
Time Frame
through study completion, on average four weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
Study acceptability will be measured as the proportion of patients who qualitatively report a positive response to at least half of exit survey themes.
Time Frame
through study completion, on average four weeks
Title
Whole body physical function
Description
Timed up and go test
Time Frame
Baseline and through study completion, on average four weeks
Title
Lower body physical function
Description
30-second chair stand test
Time Frame
Baseline and through study completion, on average four weeks
Title
Whole body strength
Description
Handgrip strength test
Time Frame
Baseline and through study completion, on average four weeks
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness test
Time Frame
Baseline and through study completion, on average four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage I-III Breast Cancer patients with plans to start chemotherapy or just started chemotherapy. Just started chemotherapy is defined as already receiving one cycle of chemotherapy. ECOG 0, 1, 2 Exclusion Criteria: Stage IV Breast cancer patients ECOG >/= 3 Stage I-III Breast Cancer patients who do not have plans to start chemotherapy or who have received more than one cycle of breast cancer chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana M Coletta, PhD, MS, RD
Phone
18012136012
Email
adriana.coletta@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana M Coletta, PhD, MS, RD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana M Coletta, PhD
Phone
801-213-6012
Email
adriana.coletta@hci.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available

Learn more about this trial

Exercise Timing in Breast Cancer Patients

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