Anatomic Stage I Breast Cancer AJCC v8NCT05025059

Exercise During Chemotherapy in Older Women With Stage I-III Breast Cancer

A study testing Discussion, Exercise Intervention and Informational Intervention in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 65 years and older, women only
Conditions the study is for: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
What is being tested?: Discussion, Exercise Intervention and Informational Intervention
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2020to 31 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
Women only
No healthy volunteers
Older adult

Who may be able to join

Age 65 years or older, female
Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Scheduled to begin adjuvant or neoadjuvant chemotherapy regimen either as standard-of-care or on study
English or Spanish speaking
Able to provide written, informed consent
Patient-assessed ability to walk and engage in moderate physical activity
Willing and able to meet all study requirements

Who cannot join

The presence of significant medical conditions that in the physician's judgement preclude participation in the exercise intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: The EXCitE Study: Exercise During Chemotherapy in Older Women With Early-Stage Breast Cancer

This clinical trial evaluates the feasibility of exercise during chemotherapy in older women with stage I-III breast cancer. Previous studies have reported that exercise may reduce the chemotherapy-toxicity risk. This trial may help researchers learn if engaging in a physical activity program is feasible in patients receiving chemotherapy for breast cancer.

Read the detailed description

PRIMARY OBJECTIVE:

Determine the feasibility of implementing a home-based exercise intervention in older adults receiving chemotherapy for early-stage breast cancer.

SECONDARY OBJECTIVES:

Describe and determine the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3-5 toxicities overall and in three risk subgroups ("low-risk," "mid-risk" and "high-risk") determined by the Cancer and Aging Research Group-Breast Cancer (CARG-BC) tool.

II. Evaluate the accuracy of the CARG-BC tool in predicting the incidence of CTCAE grade 3-5 toxicities.

III. Determine the incidence of dose-reductions, dose-delays, treatment discontinuation and reduced-dose intensity (RDI; defined as < 85% of total dose) overall and in the three risk subgroups.

IV. Determine the incidence of hospitalizations overall and in the three risk subgroups.

To examine the effect of the intervention on quality of life overall and in the three risk subgroups, as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).

VI. To examine the effect of the intervention on function overall and in the three risk subgroups.

VII. To examine the effects of the intervention on patient expectation and self-efficacy, as assessed by Outcomes Expectations for Exercise (OEE) and Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) respectively.

OUTLINE:

Patients participate in one-on-one coaching sessions with a health coach once a week (QW) to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the Walk with Ease Program (WWE) workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.

Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
Being tested: Discussion, Exercise Intervention, Informational Intervention, Medical Device Usage and Evaluation, Quality-of-Life Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DiscussionProcedure or surgery
Also called Discuss
Participate in coaching sessions
Exercise InterventionOther
Perform walking exercise
Exercise InterventionOther
Perform strength exercises
Informational InterventionOther
Receive WWE workbook and Growing Stronger Strength Training Program instruction manual
Informational InterventionOther
Maintain exercise log
Medical Device Usage and EvaluationOther
Wear fitness tracker
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete questionnaires
Questionnaire AdministrationOther
Complete questionnaires

Study groups in NCT05025059
Study group	Role	What they receive
Supportive care (coaching, exercise, questionnaire)	Experimental	Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy. Receives: Procedure: Discussion; Other: Exercise Intervention; Other: Informational Intervention; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Adherence
Will be calculated as the ratios of (a) the average number of exercise sessions completed weekly to total number of weekly targeted sessions during the period of chemotherapy (goal = 5 for walking sessions and 2 for upper-extremity exercises wearable. The mean adherence will be calculated for each patient.
Measured: Up to 1 month after chemotherapy
Compliance
Compliance will be calculated as the ratio of the average total number of valid days (>= 10 hours /day of use) to the total number of weekly targeted days (goal = 5). The mean compliance will be calculated for each patient.
Measured: Up to 1 month after chemotherapy
Retention
Will be assessed as the proportion of patients who enrolled in the study who complete all questionnaires and assessments at all time points.
Measured: Up to 1 month after chemotherapy

Secondary outcomes (6)

Incidence of adverse events (AEs)
Chemotherapy toxicity will be measured per Common Terminology Criteria for Adverse Events version 5.0. All AEs (grade 1-5) will be captured at each follow-up visit during chemotherapy.
Measured: Up to 1 month after chemotherapy
Geriatric assessment
The Wilcoxon signed rank test will be used to assess the changes of geriatric assessment measures.
Measured: Baseline up to 1 month after chemotherapy
Short Physical Performance Battery (SPPB)
The Wilcoxon signed rank test will be used to assess the changes physical performance (SBBP).
Measured: Baseline up to 1 month after chemotherapy
Quality of life questionnaires
Assessed using Functional Assessment of Cancer Therapy-Breast and Functional Assessment of Chronic Illness Therapy-Fatigue. The Wilcoxon signed rank test will be used to assess the changes of quality of life measures.
Measured: Baseline up to 1 month after chemotherapy
Outcome Expectations for Exercise (OEE) Scale Questionnaires
The Wilcoxon signed rank test will be used to assess the changes of expectations for exercise (OEE) within patient from baseline to each follow-up time point. Scale 1 (Strongly Disagree) to 5 (Strongly Agree)
Measured: Baseline up to 1 month after chemotherapy
Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires
The Wilcoxon signed rank test will be used to assess the changes self-efficacy for fatigue (PSEFSM) within patient from baseline to each follow-up time point. PSEFSM 35-36 is a 6-item scale that uses a 10-point response option ranging from "not at all confident" to "total confident.
Measured: Baseline up to 1 month after chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202031 Dec 2026

First posted27 Aug 2021
Study start3 Dec 2020
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05025059
Sponsor's protocol ID: 2019-0638
Other IDs: NCI-2021-08757, 2019-0638
Status last verified: Aug 2026
First submitted: 17 Aug 2021
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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