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NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Triple Negative Breast Cancer (TNBC) Behavior Breast Diseases Breast Neoplasms Cancer-related Fatigue Early Breast Cancer Fatigue HER2-positive Breast Cancer Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Quality of Life (QOL) Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Porto, 4099-001, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based Exercise Program

Behavioral

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]

Other names: HoPEx-Breast intervention, Exercise

Promotion of Healthy Physical Activity

Behavioral

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.

Other names: Short counseling, Control

Primary outcomes

  1. 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

    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)

  2. Fatigue

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

    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)

Secondary outcomes

  1. Exercise capacity

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

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

  2. Physical activity levels

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

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

  3. Hand grip strength

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

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

  4. Timed Up and Go

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

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

  5. Complete pathologic response rate

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

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

  6. Compliance to intervention

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

    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.

  7. Safety

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

    Reported adverse events potentially related to exercise.

  8. Compliance to questionnaires

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

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

Other outcomes

  1. Lymphedema

    Time frame: From enrolement to up to 12 months after the end of intervention period.

    Changes in arms circumferences from T0 to T2, and from T0 to 6-12m after the surgery.

  2. Disease free survival

    Time frame: 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

    Time from the beginning of neoadjuvant treatment until death or recurrence of breast cancer disease.

  3. Overall survival

    Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months

    Time from the beginning of neoadjuvant treatment until death.

  4. Health costs

    Time frame: From enrolement up to 6 months after surgery.

    Health costs estimation based on number of emergency episodes, in-hospital days, delayed day hospital sessions, off-labor days.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Universitário de Santo António

Other

Collaborators

  • Universidade do Porto

Registry information

Official study 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

Acronym: HoPEx-Breast

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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