Protein Recommendation to Increase Muscle (PRIMe): Study protocol for a randomized controlled pilot trial investigating the feasibility of a high protein diet to halt loss of muscle mass in patients with colorectal cancer
Abstract:Background: Severe muscle mass (MM) loss is a defining feature of cancer observed across all types and stages of disease and is an independent predictor of poor clinical outcomes including higher incidences of chemotherapy toxicity and decreased survival. Protein is essential to build MM, yet the optimal amount for preventing or treating muscle loss in patients with cancer remains undefined. Methods: The Protein Recommendation to Increase Muscle (PRIMe) study is a single-center, two-armed, parallel, randomized… Show more
“…Therefore, patients with history of smoking, drinking, diabetes, high tumor stage, malnutrition and low exercise ability should be given corresponding nutrition and exercise intervention according to the actual situation of the patients (41)(42)(43).…”
ObjectivesSarcopenia is associated with a poor prognosis in patients with colorectal cancer. However, the clinical factors that lead to colorectal cancer patients with sarcopenia are still unclear. The objective of this study is to develop and validate a nomogram for predicting the occurrence of sarcopenia and to provide healthcare professionals with a reliable tool for early identification of high-risk patients with colorectal cancer associated sarcopenia.MethodsA total of 359 patients diagnosed with colorectal cancer from July 2021 to May 2022 were included. All patients were randomly divided into a training (n = 287) cohort and a validation cohort (n = 72) at the ratio of 80/20. Univariate and multivariate logistic analysis were performed to evaluate the factors associated with sarcopenia. The diagnostic nomogram of sarcopenia in patients with colorectal cancer was constructed in the training cohort and validated in the validation cohort. Various evaluation metrics were employed to assess the performance of the developed nomogram, including the ROC curve, calibration curve, and Hosmer-Lemeshow test.ResultsSmoking history, drinking history, diabetes, TNM stage, nutritional status, and physical activity were included in the nomogram for the prediction of sarcopenia. The diagnostic nomograms demonstrated excellent discrimination, with AUC values of 0.971 and 0.922 in the training and validation cohorts, respectively. Moreover, the calibration performance of the nomogram is also excellent, as evidenced by the Hosmer-Lemeshow test result of 0.886.ConclusionsThe nomogram consisting of preoperative factors was able to successfully predict the occurrence of sarcopenia in colorectal cancer patients, aiding in the early identification of high-risk patients and facilitating timely implementation of appropriate intervention measures.
“…Therefore, patients with history of smoking, drinking, diabetes, high tumor stage, malnutrition and low exercise ability should be given corresponding nutrition and exercise intervention according to the actual situation of the patients (41)(42)(43).…”
ObjectivesSarcopenia is associated with a poor prognosis in patients with colorectal cancer. However, the clinical factors that lead to colorectal cancer patients with sarcopenia are still unclear. The objective of this study is to develop and validate a nomogram for predicting the occurrence of sarcopenia and to provide healthcare professionals with a reliable tool for early identification of high-risk patients with colorectal cancer associated sarcopenia.MethodsA total of 359 patients diagnosed with colorectal cancer from July 2021 to May 2022 were included. All patients were randomly divided into a training (n = 287) cohort and a validation cohort (n = 72) at the ratio of 80/20. Univariate and multivariate logistic analysis were performed to evaluate the factors associated with sarcopenia. The diagnostic nomogram of sarcopenia in patients with colorectal cancer was constructed in the training cohort and validated in the validation cohort. Various evaluation metrics were employed to assess the performance of the developed nomogram, including the ROC curve, calibration curve, and Hosmer-Lemeshow test.ResultsSmoking history, drinking history, diabetes, TNM stage, nutritional status, and physical activity were included in the nomogram for the prediction of sarcopenia. The diagnostic nomograms demonstrated excellent discrimination, with AUC values of 0.971 and 0.922 in the training and validation cohorts, respectively. Moreover, the calibration performance of the nomogram is also excellent, as evidenced by the Hosmer-Lemeshow test result of 0.886.ConclusionsThe nomogram consisting of preoperative factors was able to successfully predict the occurrence of sarcopenia in colorectal cancer patients, aiding in the early identification of high-risk patients and facilitating timely implementation of appropriate intervention measures.
“…Higher all-cause mortality was also reported for lower milk intake [ 48 ]. A low animal protein intake could result in loss of muscle mass, which could worsen clinical outcomes and increase mortality risk [ 49 , 50 ]. Taken together, emerging evidence seems to indicate low fruit and vegetable intake is associated with higher all-cause mortality, especially among colon cancer survivors.…”
Current lifestyle recommendations for cancer survivors are the same as those for the general public to decrease their risk of cancer. However, it is unclear which lifestyle behaviors are most important for prognosis. We aimed to identify which lifestyle behaviors were most important regarding colorectal cancer (CRC) recurrence and all-cause mortality with a data-driven method. The study consisted of 1180 newly diagnosed stage I–III CRC patients from a prospective cohort study. Lifestyle behaviors included in the current recommendations, as well as additional lifestyle behaviors related to diet, physical activity, adiposity, alcohol use, and smoking were assessed six months after diagnosis. These behaviors were simultaneously analyzed as potential predictors of recurrence or all-cause mortality with Random Survival Forests (RSFs). We observed 148 recurrences during 2.6-year median follow-up and 152 deaths during 4.8-year median follow-up. Higher intakes of sugary drinks were associated with increased recurrence risk. For all-cause mortality, fruit and vegetable, liquid fat and oil, and animal protein intake were identified as the most important lifestyle behaviors. These behaviors showed non-linear associations with all-cause mortality. Our exploratory RSF findings give new ideas on potential associations between certain lifestyle behaviors and CRC prognosis that still need to be confirmed in other cohorts of CRC survivors.
“…The PRIMe trial was a single-center, two-arm, open-label, randomized, controlled pilot trial conducted from August 2016 to April 2022. The protocol was published 30 and the trial was registered as NCT02788955 on ClinicalTrials.gov. 31 Clinical assessments of patients were completed at the Human Nutrition Research Unit, 32 University of Alberta (Edmonton, AB, Canada).…”
Section: Methodsmentioning
confidence: 99%
“…An overview of the timeline and assessments is provided later and in Figure 1 ; detailed descriptions are presented in the trial protocol. 30 Figure 1 Graphical illustration of the Protein Recommendation to Increase Muscle (PRIMe) study protocol. …”
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