Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer

Not Applicable

Recruiting

• Conditions: Physical Exercise
• Interventions: Other: Exercise training; Other: Control

• Registration Number: NCT04135586
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).

Detailed Description

Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.

Principal aim:

To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).

Secondary aims:

To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-20
• Study First Posted: 2019-10-22
• Study Start: 2020-01-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
• Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm

Exclusion Criteria

• Not meeting all of the above.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise training	The patients in this arm will follow an exercise program for 24 weeks (i.e., during neo-adjuvant treatment), with two sessions per week including both aerobic and resistance training. Exercise intensity will range between 65% and 100% of the maximum score in the scale of Rated Perceived Exertion (RPE).
Control	Control	The patients follow their usual habits as well as a Yoga program. They will also receive educational sessions on the benefits of regular physical activity (brisk walking).

Primary Outcome Measures

Name	Time	Method
handgrip strength	Change from baseline to end of intervention (i.e., after 24 weeks)	handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
muscle dynamic strength	Change from baseline to end of intervention (i.e., after 24 weeks)	Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
Cardiorespiratory fitness	Change from baseline to end of intervention (i.e., after 24 weeks)	peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion

Secondary Outcome Measures

Name	Time	Method
Body composition (fat mass)	Change from baseline to end of intervention (i.e., after 24 weeks)	fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Body composition (lean body mass)	Change from baseline to end of intervention (i.e., after 24 weeks)	lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])	Change from baseline to end of intervention (i.e., after 24 weeks)	The QLQ-C30 is a multidimensional cancer HRQoL questionnaire that contains 30 items assessing six functional and nine symptom scales. Results from this questionnaire are transformed into scores ranging from 0 to 100 according to European Organization for Research and Treatment of Cancer (EORTC) scoring, with higher scores in the functioning scales indicating a better functional status and global HRQoL, and higher scores on the symptoms' scales indicating more symptoms.

Trial Locations

Locations (2)

Hospital Universitario Quirónsalud de Pozuelo (HUQP); 🇪🇸 Madrid, Spain

Lgcortijo@Gmail.Com; 🇪🇸 Madrid, Spain