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

Centro Hospitalar Universitário de Santo António

Status: Active, not recruiting

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

Treatments: Behavioral: Promotion of Healthy Physical Activity; Behavioral: Home-based exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06782698

002-24 DEFI 02 CE 02

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (must meet all):

• Adult patients,
• Any gender,
• Diagnosed with breast cancer, of HER2-positive or triple-negative subtypes,
• Proposed to neoadjuvant systemic cancer therapy. May be included: Patients non-eligible for anthracyclines or anti-HER2 therapies; patients with oligometastatic disease proposed for primary/neoadjuvant systemic cancer therapy with intent of radical treatment.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Home-based exercise program

Experimental group

Description:

Participants allocated to the intervention arm will follow a home-based program, consisting of two initially supervised explanatory sessions, followed by home sessions of muscular training (twice per week), complemented with additional periods of aerobic exercise (20-30min trice per week). They will also receive routine short counseling for promotion of physical activity.

Treatment:

Behavioral: Home-based exercise program

Behavioral: Promotion of Healthy Physical Activity

Short counselling for promotion of physical activity

Active Comparator group

Description:

Participants allocated to the control arm will receive routine short counseling for promotion of physical activity, as recommended by the Portuguese Directorate-General of Health (Mendes R, et al. 2020)

Treatment:

Behavioral: Promotion of Healthy Physical Activity