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NCT Number: NCT04135586

Effects of a Physical Exercise Intervention 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).

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Key information

Conditions

Physical Exercise Behavior Motor Activity

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Quirónsalud de Pozuelo (HUQP), Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

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

Other

Yoga + educational program

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Acronym: NEOLIFE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2019
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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