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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Pathologists who evaluate the pathological response are masked from the study-arm

Study Groups

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Home-based exercise program

Participants 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.

Group Type EXPERIMENTAL

Home-based exercise program

Intervention Type 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.\[Nilsen TS, 2018\]

Promotion of Healthy Physical Activity

Intervention Type 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.

Short counselling for promotion of physical activity

Participants 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)

Group Type ACTIVE_COMPARATOR

Promotion of Healthy Physical Activity

Intervention Type 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.

Interventions

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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.\[Nilsen TS, 2018\]

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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HoPEx-Breast intervention Exercise Short counseling Control

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rita Carrilho Pichel

MD / PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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António Araújo, MD PhD

Role: STUDY_DIRECTOR

Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Serviço de Oncologia Médica, Porto, Portugal. Oncology Research, UMIB, ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Porto, Portugal.