Impact of Exercise on Quality of Life of EBC Patients on Treatment With Adjuvant AI With or Without CDK4/6 Inhibitors

NCT07215364 | Not Yet Recruiting

• 2 other identifiers: GEICAM/2023-092025-522848-40-00
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 5

Brief Summary

This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and aerobic exercise program) and the control group. The study will begin with a pilot phase involving approximately 74 patients. Approximately 37 patients in the experimental group will follow a 6-month training program consisting of exercise sessions three alternate days per week (combining resistance and aerobic exercise). Approximately 37 patients in the control group will receive standard medical care. These patients will be provided with international exercise guidelines for cancer patients. Patients will continue with their assigned physical activity intervention until the maximum number of months for the intervention, unacceptable toxicity, discontinuation of hormone therapy, or withdrawal of consent-whichever occurs first.

Conditions

Early-stage Breast Cancer

Keywords

early-stage breast cancer (EBC); HR-positive; HER2-negative

Outcome Measures

Primary Outcomes (1)

• Effect of a training program in quality of life questionnaire (QoL)-related to endocrine therapy

  To determine the changes from baseline in the QoL-related to endocrine therapy (ET) symptoms measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 45 (EORTC QLQ-BR45) questionnaire (questions 54-56, 63-69). To calculate the scores for each desirable dimension Scoring Manuals will be followed. Summary statistics (mean, mean confidence interval (CI), standard deviation, median and range) of absolute scores and their changes from baseline will be summarized at each assessment time. The comparison between treatment groups will be performed using a linear mixed model. Patients will complete this questionnaire at at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.

  Through study treatment, and average of 12 months

Secondary Outcomes (12)

• Change from baseline in global QoL

  Through study treatment, and average of 12 months

• Aromatase inhibitor associated musculoskeletal syndrome (AIMSS)

  Through study treatment, and average of 12 months

• Fatigue

  Through study treatment, and average of 12 months

• Compliance to treatment

  Through study treatment, and average of 12 months

• Body composition

  Through study treatment, and average of 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Approximately 37 patients in the experimental group will perform a 6-month training program consisting of exercise sessions 3 alternating days per week (combined resistance + aerobic exercise).

Behavioral: Training program

Control group

NO INTERVENTION

Approximately 37 patients in the control group will receive usual health care. This patients' group will be provided with the international exercise guidelines for cancer patients.

Interventions

Training program BEHAVIORAL

Training program consist on physical activity sessions (combined resistance plus aerobic exercises) that will be performed 3 times per week every-other-day.

Experimental group

Eligibility Criteria

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

You may qualify if:

• Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
• Patients ≥18 years of age at signing of ICD.
• Documented histologically confirmed HR+/HER2- invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance).
• HR and HER2 assessments are performed under institutional guidelines.
• HR testing should utilize an assay consistent with the most recent American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) Guidelines.
• HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
• Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines.
• Note: Patients that are candidate to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.
• Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-/adjuvant systemic CT.
• Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines.
• Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program.
• Fluent Spanish language skills for the complete comprehension of the questionnaires.
• With the consent of the investigator for participation in physical training and considering the medical history of the patient.

You may not qualify if:

• Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
• Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
• Patients have musculoskeletal injuries.
• Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
• Patients with weight over 150kg.
• Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.
• Patients have any cardiovascular contraindication to physical training by the investigator.
• Patients have been performing supervised training, either aerobic and/or resistance training (at a gym \[group or individual classes\] or in a specific sport), at least 2 days per week in the past 6 months.
• No access and/or unable to manage the website and other digital tools (i.e. applications) for training sessions.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead

Study Sites (5)

Institut Català d'Oncología (ICO) L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Quirón Sagrado Corazón de Sevilla

Seville, 41013, Spain

Location

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Multidisciplinary academic group leading in breast cancer research, education, and patient support

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Hospital Universitario Clínico San Cecilio, Granada, Spain

  STUDY DIRECTOR

• Study Director

  Hospital Quirón Sagrado Corazón-Sevilla, Sevilla, Spain

  STUDY DIRECTOR

Central Study Contacts

Study Project Manager

CONTACT

+34916592870; inicio_ensayos@geicam.org

Start-Up Unit Manager

CONTACT

+34916592870; inicio_ensayos@geicam.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 10, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)