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

Sponsor

Universidad Europea de Madrid (Other)

Overall Status

Unknown status

CT.gov ID

NCT04135586

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Physical Exercise	Other: Exercise training Other: Control	N/A

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:

Secondary aims:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Physical exercise intervention (24 weeks)Physical exercise intervention (24 weeks)

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise 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).	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.
Other: 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).	Other: Control Yoga + educational program

Arm

Intervention/Treatment

Experimental: Exercise

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).

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.

Other: 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).

Other: Control

Yoga + educational program

Outcome Measures

Primary Outcome Measures

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
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)
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)

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alejandro Lucia, Professor, Universidad Europea de Madrid

ClinicalTrials.gov Identifier:

NCT04135586

Other Study ID Numbers:

UEM Quirón

First Posted:

Oct 22, 2019

Last Update Posted:

Oct 22, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alejandro Lucia, Professor, Universidad Europea de Madrid

exercise

high interval training

resistance exercise

Study Results

No Results Posted as of Oct 22, 2019