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

May 9, 2023 updated by: Alejandro Lucia, Universidad Europea de Madrid

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

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Quirónsalud de Pozuelo (HUQP)
        • Contact:
        • Principal Investigator:
          • Lucía G Cortijo
      • Madrid, Spain
        • Recruiting
        • Lgcortijo@Gmail.Com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).
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).
Yoga + educational program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: 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
Change from baseline to end of intervention (i.e., after 24 weeks)
muscle dynamic strength
Time Frame: 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)
Change from baseline to end of intervention (i.e., after 24 weeks)
handgrip strength
Time Frame: 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)
Change from baseline to end of intervention (i.e., after 24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])
Time Frame: 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.
Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (fat mass)
Time Frame: 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
Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (lean body mass)
Time Frame: 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
Change from baseline to end of intervention (i.e., after 24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 20, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UEM Quirón

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Exercise

Clinical Trials on Exercise training

3
Subscribe