Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversidad de La Frontera
About this trial
Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Postmenopausal women with breast cancer in stages I, II and III with luminal breast tumor, HER2+ or TNBC
Indication for neoadjuvant chemotherapy
Candidates for curative breast surgery
Body mass index: 18.5 <BMI <30 kg/m2
Disqualifiers
Present comorbidities that interact with the metabolism and mobility of the muscles of the body and that do not allow the (safe) performance of strength exercises (e.g., debilitating arthritis, all neurological disorders, paralysis, among others).
Severe or uncontrolled cardiovascular disease, cardiac ejection fraction less than 50%
Previous antineoplastic treatment
Use of nutritional supplements (leucine, glutamine, casein, whey protein, fatty acids and creatine).
Trial design
Design model
Parallel
Treatments tested in this trial
Prehabilitation with resistance-exercise training
Other interventionThe volunteers in the intervention group will be subjected to 16 - 20 weeks of whole-body resistance-type exercise training (2x/wk).
Usual care program
Other interventionThe volunteers in the intervention group will be subjected to usual care (diagnosis confirmation, chemotherapy treatment planning and an initial education session).
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Prehabilitation intervention programExperimental treatment 1 intervention
Group B: Usual Care ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in skeletal muscle mass (measured via Computed tomography (CT) scan)
Cross-sectional area of the quadriceps via single-slice CT scan
Time frame
Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgerySecondary outcomes
1
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing)
Maximal strength assessment via 1RM testing of horizontal row, lat pull down, chest press, leg press, and leg extension)
Time frame
Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery2
Change in hand grip strength (measured via JAMAR handheld dynamometer)
Maximal strength assessment via 1RM testing of JAMAR handheld dynamometer.
Time frame
Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery3
Change in physical performance measured via Short physical performance battery
Measurement of physical performance via SPPB Short physical performance battery (0 to 12 points, whether higher scores mean a better outcome).
Time frame
Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgery4
Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Measurement of quality of life via EORTC QLQ-30, this questionnaire has 30 question covering functional state and cancer related symptoms. Besides, there are two specific question covering the "overall health" and "overall quality of life". The scores obtained are standardized and a score between 0 and 100 is obtained. High values on the global health and functional status scales indicate a better quality of life. However, high values on the symptom scale indicate a lower quality of life
Time frame
Before training (week 0), and after training (up to 20 weeks) and 4 weeks post surgerySponsors and contacts
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Source ClinicalTrials.gov