Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life i… (NCT06782698) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients
Portugal50 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-related quality of life
Timeframe: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
2
Fatigue
Timeframe: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery
Trial details
NCT IDNCT06782698
SponsorCentro Hospitalar Universitário de Santo António