Clinical trial NCT05025059: Exercise During Chemotherapy in Older Women With Stage I-III Breast Cancer
Official title: The EXCitE Study: Exercise During Chemotherapy in Older Women With Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

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

SECONDARY OBJECTIVES:

I. 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.

V. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Adherence
timeFrame: Up to 1 month after chemotherapy
measure: Compliance
timeFrame: Up to 1 month after chemotherapy
measure: Retention
timeFrame: Up to 1 month after chemotherapy
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 1 month after chemotherapy
measure: Geriatric assessment
timeFrame: Baseline up to 1 month after chemotherapy
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline up to 1 month after chemotherapy
measure: Quality of life questionnaires
timeFrame: Baseline up to 1 month after chemotherapy
measure: Outcome Expectations for Exercise (OEE) Scale Questionnaires
timeFrame: Baseline up to 1 month after chemotherapy
measure: Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires
timeFrame: Baseline up to 1 month after chemotherapy
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Meghan Karuturi
role: PRINCIPAL_INVESTIGATOR
References: