NCT04135586

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jan 2020Dec 2026

First Submitted

Initial submission to the registry

October 8, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

6.8 years

First QC Date

October 8, 2019

Last Update Submit

June 26, 2024

Conditions

Physical Exercise

Keywords

exercisehigh interval trainingresistance exercise

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • 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)

  • Body composition (fat mass)

    Change from baseline to end of intervention (i.e., after 24 weeks)

  • Body composition (lean body mass)

    Change from baseline to end of intervention (i.e., after 24 weeks)

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Exercise trainingOTHER

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.

Exercise
ControlOTHER

Yoga + educational program

Control

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not meeting all of the above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Quirónsalud de Pozuelo (HUQP)

Madrid, Spain

RECRUITING

Lgcortijo@Gmail.Com

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Physical exercise intervention (24 weeks)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 22, 2019

Study Start

January 1, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations

ES(2)