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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-75
SponsorUniversidad Europea de Madrid

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not meeting all of the above.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise training

    Other intervention

    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 intervention

    Yoga + educational program

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Cardiorespiratory fitness

peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion

Time frame
Change from baseline to end of intervention (i.e., after 24 weeks)
2

muscle dynamic strength

Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)

Time frame
Change from baseline to end of intervention (i.e., after 24 weeks)
3

handgrip strength

handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)

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

Secondary outcomes

1

Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])

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.

Time frame
Change from baseline to end of intervention (i.e., after 24 weeks)
2

Body composition (fat mass)

fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry

Time frame
Change from baseline to end of intervention (i.e., after 24 weeks)
3

Body composition (lean body mass)

lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry

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

Other outcomes

Sponsors and contacts

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