NCT06782698Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 1 Apr 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- Centro Hospitalar Universitário de Santo António
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06782698
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Apr 2024 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.