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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centro Hospitalar Universitário de Santo António · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Home-based exercise program	The home-based program follows the National recommendations on Physical Exercise for Cancer Patients \[Bruno RC, 2023\]. It is logbook-guided and technology-enabled. It consists of: * Two initial supervised explanatory sessions, in the Physic and Rehabilitation Medicine Gym of our institution. * Followed by 2 muscular training sessions + 3 additional periods of aerobic exercise per week in their home environment until the end of neoadjuvant treatment. Patients are given a logbook with instructions and a sports bracelet for heart rate monitoring. The training sessions will be monitored by smartwatch heart rate measurements and self-notion of effort according to Borg Categorization \[Borg GA, 1982\] and recorded by the participants in the Mi Fitness application or an Exercise Diary.\[Nilsen TS, 2018\]
BEHAVIORAL	Promotion of Healthy Physical Activity	The short counseling consists of at least one opportunistic talk for promotion of physical activity, taking up to 5 minutes, during the Medical Oncology appointment or during Physical Assessments at T0. It should follow the instructions of the Portuguese Directorate-General of Health, "Short Counselling for the Promotion of Physical Activity", including the delivery of a Physical Activity Guide plus a Auxiliar of Decision or a Plan of Action or Maintenance.\[Mendes R, 2020\] All patients will receive a Guide about Nutrition for Cancer Patients \[Capela AM, 2023\] and may be offered Nutritional, Psychological or other additional consultations according to clinical judgement of the Medical Oncologist.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: Portugal