Clinical trial NCT06782698: Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients
Official title: Home-Based Physical Exercise During Neoadjuvant Treatment for Improving Fatigue and Quality of Life in Early Breast Cancer Patients (HoPEx-Breast): a Pragmatic Randomised Controlled Trial in a Portuguese Public Hospital
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Triple Negative Breast Cancer (TNBC)
HER2-Positive Breast Cancer
Early Breast Cancer
Cancer-related Fatigue
Quality of Life (QOL)
Keywords: Exercise
Home-based
Breast cancer
Fatigue
Quality of Life
Patient-reported outcomes
Physical activity
Neoadjuvant
Lead sponsor: Centro Hospitalar Universitário de Santo António
Sponsor class: OTHER
Collaborators: name: Oncology Research, Unit for Multidisciplinary Research in Biomedicine (UMIB), ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Portugal
name: Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Porto, Portugal
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Fatigue
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
Secondary outcomes:
measure: Exercise capacity
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Physical activity levels
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Hand grip strength
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Timed Up and Go
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Complete pathologic response rate
timeFrame: From 1 month up to 2 months after breast surgery. Data can be restropectively collected from the pathologic report after this period.
measure: Compliance to intervention
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Safety
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
measure: Compliance to questionnaires
timeFrame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
Other outcomes:
measure: Lymphedema
timeFrame: From enrolement to up to 12 months after the end of intervention period.
measure: Disease free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 120 months
measure: Health costs
timeFrame: From enrolement up to 6 months after surgery.
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António
Study officials:
affiliation: Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Serviço de Oncologia Médica, Porto, Portugal. Oncology Research, UMIB, ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Porto, Portugal.
name: António Araújo, MD PhD
role: STUDY_DIRECTOR
References: