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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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
Perform walking exercise
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Karuturi, Principal investigator, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXCitE Study: Exercise During Chemotherapy in Older Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05025059
- Acronym / sponsor ID
- 2019-0638
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (coaching, exercise, questionnaire) | Experimental | Procedure: Discussion, Other: Exercise Intervention, Other: Informational Intervention, Other: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- The presence of significant medical conditions that in the physician's judgement preclude participation in the exercise intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussParticipate in coaching sessions | Procedure or surgery | Supportive care (coaching, exercise, questionnaire) |
| Exercise InterventionPerform walking exercise | Other | Supportive care (coaching, exercise, questionnaire) |
| Exercise InterventionPerform strength exercises | Other | Supportive care (coaching, exercise, questionnaire) |
| Informational InterventionReceive WWE workbook and Growing Stronger Strength Training Program instruction manual | Other | Supportive care (coaching, exercise, questionnaire) |
| Informational InterventionMaintain exercise log | Other | Supportive care (coaching, exercise, questionnaire) |
| Medical Device Usage and EvaluationWear fitness tracker | Other | Supportive care (coaching, exercise, questionnaire) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete questionnaires | Other | Supportive care (coaching, exercise, questionnaire) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (coaching, exercise, questionnaire) |
Primary outcome
Adherence
Time frame: Up to 1 month after chemotherapy
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.
Compliance
Time frame: Up to 1 month after chemotherapy
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.
Retention
Time frame: Up to 1 month after chemotherapy
Will be assessed as the proportion of patients who enrolled in the study who complete all questionnaires and assessments at all time points.
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 1 month after chemotherapy
Geriatric assessment
Time frame: Baseline up to 1 month after chemotherapy
Short Physical Performance Battery (SPPB)
Time frame: Baseline up to 1 month after chemotherapy
Quality of life questionnaires
Time frame: Baseline up to 1 month after chemotherapy
Outcome Expectations for Exercise (OEE) Scale Questionnaires
Time frame: Baseline up to 1 month after chemotherapy
Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires
Time frame: Baseline up to 1 month after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Karuturi principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Up to 1 month after chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.