Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol

Abstract

Background: Cancer cachexia and exacerbated fatigue represent two hallmarks in cancer patients, negatively impacting their exercise tolerance and ultimately their quality of life. However, the characterization of patients' physical status and exercise tolerance and, most importantly, their evolution throughout cancer treatment may represent the first step in efficiently counteracting their development with prescribed and tailored exercise training. In this context, the aim of the PROTECT-01 study will be to investigate the evolution of physical status, from diagnosis to the end of first-line treatment, of patients with one of the three most common cancers (i.e., lung, breast, and colorectal). Methods: The PROTECT-01 cohort study will include 300 patients equally divided between lung, breast and colorectal cancer. Patients will perform a series of assessments at three visits throughout the treatment: (1) between the date of diagnosis and the start of treatment, (2) 8 weeks after the start of treatment, and (3) after the completion of first-line treatment or at the 6-months mark, whichever occurs first. For each of the three visits, subjective and objective fatigue, maximal voluntary force, body composition, cachexia, physical activity level, quality of life, respiratory function, overall physical performance, and exercise tolerance will be assessed. Discussion: The present study is aimed at identifying the nature and severity of maladaptation related to exercise intolerance in the three most common cancers. Therefore, our results should contribute to the delineation of the needs of each group of patients and to the determination of the most valuable exercise interventions in order to counteract these maladaptations. This descriptive and comprehensive approach is a prerequisite in order to elaborate, through future interventional research projects, tailored exercise strategies to counteract specific symptoms that are potentially cancer type-dependent and, in fine , to improve the health and quality of life of cancer patients. Moreover, our concomitant focus on fatigue and cachexia will provide insightful information about two factors that may have substantial interaction but require further investigation. Trial registration: This prospective study has been registered at ClinicalTrials.gov (NCT03956641), May, 2019.

Longitudinal Assessment of Physical Activity, Fitness, Body Composition, Immunological Biomarkers, and Psychological Parameters During the First Year After Diagnosis in Women With Non-Metastatic Breast Cancer: The BEGYN Study Protocol

“…Whereas most studies investigating the influence of physical activity in breast cancer patients focus on specific activities for three months or less, the BEGYN study will quantify the daily physical activity and cardiorespiratory fitness of breast cancer patients based on objective measurements in the context of the oncological therapy for 12 months after diagnosis. Multiple studies have shown that physical activity can have positive effects in breast cancer patients ( 4 – 6 , 33 – 35 , 37 ). Guidelines recommend physical activity during breast cancer treatment, in example in the United States ( 102 ), in Great Britain ( 103 ), in Germany ( 39 ) and others.…”

“…To our knowledge, the BEGYN study is one of the largest studies with a very broad approach in breast cancer patients that will allow to identify associations between physical, psychological and laboratory variables, thus linking aspects that are often studied separately in breast cancer patients. Regarding the assessment of physical activity, it will be of particular interest to discuss the results of the BEGYN study in the light of other ongoing highly innovative studies such as the PROTECT study which also includes patients with colorectal cancer and lung cancer ( 6 ). One of the major strengths is the continuous recording of the patient’s physical activity and well-being by diary and by use of a fitness tracker since physical activity encompasses not only explicit sports activities, which may last a few hours per week, but also activity during everyday activities.…”

“…Various forms of physical activity have been proposed, such as yoga, Tai Chi Chuan, Nordic walking, jogging, weight training, cycling, dancing and many others ( 20 , 36 , 37 , 47 ). However, it has been claimed that individualized recommendations are needed to meet the needs of the patient ( 6 , 105 ). By using the concept of metabolic equivalents (MET), the BEGYN study will allow comparing effects of physical activities of similar intensities independent of the type of exercise.…”

“…Historic recommendations to avoid physical activity during cancer treatment to save all energy for fighting the disease have proven wrong ( 1 – 6 ). Breast cancer is the most common cancer in women, accounting for more than 680.000 deaths per year worldwide ( 7 ).…”

Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers

“…Currently, neoadjuvant and adjuvant chemotherapies are extensively used in breast cancer patients to reduce tumor development and improve disease-free survival, but also leads to severe off-target side-effects ( Maughan et al, 2010 ; Redden and Fuhrman, 2013 ; Fisusi and Akala, 2019 ; Schirrmacher, 2019 ). Among these treatment-related side effects, both pre-clinical and clinical studies highlighted that chemotherapeutic agents result in major skeletal muscle deconditioning and, together with exacerbated fatigue, are part of a vicious cycle which negatively impacts their quality of life ( Berger et al, 2015 ; Caan et al, 2018 ; Aleixo et al, 2019 ; Cespedes Feliciano et al, 2019 ; Hiensch et al, 2019 ; Mallard et al, 2020 ). Although breast cancer represents the most deadly female cancer, 5-year survival rate is over 90% ( National Cancer Institute, Surveillance, Epidemiology, and End Result program, 2019 ) emphasizing the critical need to fight long-lasting effects observed in survivors such as skeletal muscle deconditioning.…”