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

NCT06782698 | Active Not Recruiting

• 1 other identifier: 002-24 DEFI 02 CE 02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Reply to questionnaires of fatigue and quality of life, at T0, T1 and T2
3. 3.Adhere to routine medical oncology visits, treatments and exams
4. 4.Receive a exercise book, with exercise instructions and calendar
5. 5.Have two in-person lessons about the exercise program
6. 6.Visit the hospital 1 additional time, to have the second lesson
7. 7.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.

Conditions

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

Keywords

Exercise; Home-based; Breast cancer; Fatigue; Quality of Life; Patient-reported outcomes; Physical activity; Neoadjuvant

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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)

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

Secondary Outcomes (8)

• Exercise capacity

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

• Physical activity levels

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

• Hand grip strength

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

• Timed Up and Go

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

• Complete pathologic response rate

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

Other Outcomes (4)

• Lymphedema

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

• Disease free survival

  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

• Overall survival

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

Study Arms (2)

Home-based exercise program

EXPERIMENTAL

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.

Behavioral: Home-based exercise program; Behavioral: Promotion of Healthy Physical Activity

Short counselling for promotion of physical activity

ACTIVE COMPARATOR

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)

Behavioral: Promotion of Healthy Physical Activity

Interventions

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.\[Nilsen TS, 2018\]

Also known as: HoPEx-Breast intervention, Exercise

Home-based exercise program

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.

Also known as: Short counseling, Control

Home-based exercise program; Short counselling for promotion of physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar Universitário de Santo António: lead
• Oncology Research, Unit for Multidisciplinary Research in Biomedicine (UMIB), ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Portugal: collaborator
• Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Porto, Portugal: collaborator

Study Sites (1)

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

Porto, 4099-001, Portugal

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms; Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• António Araújo, MD PhD

  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.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Pathologists who evaluate the pathological response are masked from the study-arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD / PI

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 20, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the registration of study and for five years after the closure of the study.

Locations

PT (1)