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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135586
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alejandro Lucia, 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).

Condition or disease Intervention/treatment Phase
Physical Exercise Other: Exercise training Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Alejandro Lucia, Professor, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT04135586    
Other Study ID Numbers: UEM Quirón
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Lucia, Universidad Europea de Madrid:
exercise
high interval training
resistance exercise