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

Physical Exercise Clinical Trial

— NEOLIFE  

Official title:

Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135586
• Other study ID #: UEM Quirón
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Exercise

Intervention

Other:
• Exercise training
Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
• Control
Yoga + educational program

Locations

Country	Name	City	State
Spain	Hospital Universitario Quirónsalud de Pozuelo (HUQP)	Madrid
Spain	Lgcortijo@Gmail.Com	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness	peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion	Change from baseline to end of intervention (i.e., after 24 weeks)
Primary	muscle dynamic strength	Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)	Change from baseline to end of intervention (i.e., after 24 weeks)
Primary	handgrip strength	handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)	Change from baseline to end of intervention (i.e., after 24 weeks)
Secondary	Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])	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.	Change from baseline to end of intervention (i.e., after 24 weeks)
Secondary	Body composition (fat mass)	fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry	Change from baseline to end of intervention (i.e., after 24 weeks)
Secondary	Body composition (lean body mass)	lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry	Change from baseline to end of intervention (i.e., after 24 weeks)