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Triple Negative Breast Cancer (TNBC)HoPEx-BreastNCT06782698

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

A study testing Home-based exercise program and Promotion of Healthy Physical Activity in people with Triple Negative Breast Cancer (TNBC) and HER2-Positive Breast Cancer, run by Centro Hospitalar Universitário de Santo António at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home-based exercise program and Promotion of Healthy Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePortugal
Study dates
1 Apr 2024to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António

    Porto, 4099-001

Other trials in Portugal

About this study

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

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.

Read more

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.
Being tested
Home-based exercise program, Promotion of Healthy Physical Activity
Keywords
Exercise, Home-based, Breast cancer, Fatigue, Quality of Life, Patient-reported outcomes, Physical activity, Neoadjuvant
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based exercise programBehavioural

    Also called HoPEx-Breast intervention, Exercise

    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]

  • Promotion of Healthy Physical ActivityBehavioural

    Also called Short counseling, Control

    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.

Study groups in NCT06782698
Study groupRoleWhat they receive
Home-based exercise programExperimentalParticipants 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.
Receives: Behavioral: Home-based exercise program; Behavioral: Promotion of Healthy Physical Activity
Short counselling for promotion of physical activityActive comparatorParticipants 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)
Receives: Behavioral: Promotion of Healthy Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    Changes in health-related quality of life, measured by EORTC QLQ-30, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2)

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  2. Fatigue

    Changes in patient-reported fatigue, measured by FACIT-Fatigue, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2)

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

Secondary outcomes (8)

  1. Exercise capacity

    Change on exercise capacity, measured as 6MWT distance, from T0 to T1 and from T0 to T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  2. Physical activity levels

    Change on physical activity levels, measured by IPAQ-SF questionnaire (or by accelerometer), from T0 to T1 and from T0 to T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  3. Hand grip strength

    Change on hand grip strength, from T0 to T1 and from T0 to T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  4. Timed Up and Go

    Change on "Timed Up and Go", from T0 to T1 and from T0 to T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  5. Complete pathologic response rate

    Percentage of participants of each arm that achieved complete pathological response, as assessed by a dedicated pathologist from our institution, blinded for the intervention.

    Measured: From 1 month up to 2 months after breast surgery. Data can be restropectively collected from the pathologic report after this period.

  6. Compliance to intervention

    Rate of participants that accepted to participate, that completed intervention, and the percentage of programed exercise sessions that were completed ", at T0, T1 and T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  7. Safety

    Reported adverse events potentially related to exercise.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

  8. Compliance to questionnaires

    Rate of participants who replied to the quality of life and fatigue questionnaires, at T0, T1 and T2.

    Measured: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start1 Apr 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782698
Sponsor's protocol ID
002-24 DEFI 02 CE 02
Acronym
HoPEx-Breast
Status last verified
Jan 2025
First submitted
13 Jan 2025
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymized individual participant data that will support the findings of this study will be available upon justified request to the corresponding author. The request will be analyzed by the research team and by the ethical and data protection committees of the institution.

Questions about this trial

What is this clinical trial studying?

A study testing Home-based exercise program and Promotion of Healthy Physical Activity in people with Triple Negative Breast Cancer (TNBC) and HER2-Positive Breast Cancer, run by Centro Hospitalar Universitário de Santo António at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06782698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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