Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Triple Negative Breast Cancer (TNBC); HER2-Positive Breast Cancer; Early Breast Cancer; Cancer-related Fatigue; Quality of Life (QOL)

• Registration Number: NCT06782698
• Lead Sponsor: Centro Hospitalar Universitário de Santo António

Brief Summary

The goal of this trial is to learn if a home-based exercise program (intervention) reduces fatigue and improves quality of life in adult patients with early breast cancer who are proposed for preoperative chemotherapy.

Conducted at Centro Hospitalar Universitário de Santo António, Porto, Portugal. It compares a structured exercise program prescribed by the physical and rehabilitation medicine team to routine counseling for physical activity by the medical oncologist.

All participants will:

1. Visit the hospital 3 times for physical assessments, at beginning of chemotherapy (T0), at 3-months (T1) and 1 month after surgery (T2)

2. Reply to questionnaires of fatigue and quality of life, at T0, T1 and T2

3. Adhere to routine medical oncology visits, treatments and exams

Participants of the intervention-arm will additionally:

1. Receive a exercise book, with exercise instructions and calendar

2. Have two in-person lessons about the exercise program

3. Visit the hospital 1 additional time, to have the second lesson

4. Wear a sport bracelet while exercising, to monitor heart rate Recruitment began in April 2024, with results to be shared in medical publications and conferences.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients that do not perform any neoadjuvant antineoplastic therapy, for example because of refusal, impeditive comorbidities, re-staging or other reasons.
• Contraindications for exercise or impediments to perform the intervention program, because of previous comorbidities or according to medical assessment (e.g. blindness).
• Patients who are unable to take questionnaires because of language or cognitive barriers (even with small help from a relative or investigator, still cannot answer properly).
• Luminal-like subtype, with hormonal receptor expression and HER2-negative.

Individual participants will be discontinued from the trial, in agreement with their physician where appropriate, if any health problem arises that will significantly affect their safety to participate in exercise for more than one month or if the participant decides to withdraw their consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Changes in patient-reported fatigue, measured by FACIT-Fatigue, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2)
Health-related quality of life	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Changes in health-related quality of life, measured by EORTC QLQ-30, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2)

Secondary Outcome Measures

Name	Time	Method
Exercise capacity	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Change on exercise capacity, measured as 6MWT distance, from T0 to T1 and from T0 to T2.
Physical activity levels	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Change on physical activity levels, measured by IPAQ-SF questionnaire (or by accelerometer), from T0 to T1 and from T0 to T2.
Hand grip strength	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Change on hand grip strength, from T0 to T1 and from T0 to T2.
Timed Up and Go	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Change on "Timed Up and Go", from T0 to T1 and from T0 to T2.
Complete pathologic response rate	From 1 month up to 2 months after breast surgery. Data can be restropectively collected from the pathologic report after this period.	Percentage of participants of each arm that achieved complete pathological response, as assessed by a dedicated pathologist from our institution, blinded for the intervention.
Compliance to intervention	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Rate of participants that accepted to participate, that completed intervention, and the percentage of programed exercise sessions that were completed ", at T0, T1 and T2.
Safety	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Reported adverse events potentially related to exercise.
Compliance to questionnaires	From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery	Rate of participants who replied to the quality of life and fatigue questionnaires, at T0, T1 and T2.

Trial Locations

Locations (1)

Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António; 🇵🇹 Porto, Portugal