Protein Recommendation to Increase Muscle

This is a feasibility study to test the potential efficacy of diets of different amounts of protein and calories for patients with cancer. We hypothesize that nutritional deficits play a significant role in muscle loss and that nutritional therapy is an important first step in reversing or preventing muscle loss and maintaining/improving physical function.

Sex

All

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

* Ambulatory adults 18 - 85 years of age;
* Able to communicate in English;
* Recent diagnosis of colorectal cancer (stage II, III or IV);
* Able to complete all baseline assessments within 2 weeks of commencement of chemotherapy or chemoradiotherapy (when applicable);
* ≥1 year life expectancy and believed to be able to complete 12 weeks of intervention (based on clinical judgment);
* Able to provide a blood sample;
* Adequate hepatic function, as confirmed by medical records and to be checked with patient's oncologist;
* Adequate renal function, as confirmed by medical records and to be checked with patient's oncologist;
* If a woman of childbearing potential, she must agree to use an effective form of contraception during the study (are considered effective forms of contraception: abstinence, a hormonal contraceptive, or a double-barrier method).

Exclusion Criteria:

* Acute inflammation assessed by neutrophil/leukocyte ratio or in consultation with oncologist;
* Ongoing (non-treatment related) nutritional impact symptoms that would impact ability to follow dietary recommendations (ie. anorexia);
* Severe food restrictions (severe food allergy or dietary pattern - e.g. vegetarian);
* Current medical condition that impacts the patients ability to take part in study or impacts the ability to increase muscle (e.g. cachexia, post-surgical wound infection, muscular dystrophy or any degenerative muscle disease or condition);
* Individuals with pacemakers;
* Comorbidities: active treatment for another cancer site, major chronic conditions that would interfere with dietary restriction such as recent myocardial infarction, unstable angina, stroke, or unstable disease such as congestive heart failure;
* Women who are pregnant or breast-feeding;
* Body weight \> 450 lb due to limit of body composition measurement instrumentation;
* Presenting with any health condition that would severely affect nutrient absorption (e.g.: enteric fistula);
* Patients diagnosed with metabolic disorders in consultation with the oncologist (e.g. uncontrolled diabetes, recent diagnosis (\< 3 months) thyroid disease);
* Cognitive impairment or dementia.

• BACKGROUNDPrado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6. PMID 18539529
• BACKGROUNDPrado CM, Lieffers JR, Bowthorpe L, Baracos VE, Mourtzakis M, McCargar LJ. Sarcopenia and physical function in overweight patients with advanced cancer. Can J Diet Pract Res. 2013 Summer;74(2):69-74. doi: 10.3148/74.2.2013.69. PMID 23750978
• BACKGROUNDPrado CM, Lieffers JR, Bergsten G, Mourtzakis M, Baracos VE, Reiman T, Sawyer MB, McCargar LJ. Dietary patterns of patients with advanced lung or colorectal cancer. Can J Diet Pract Res. 2012 Winter;73(4):e298-303. doi: 10.3148/73.4.2012.e298. PMID 23217447
• BACKGROUNDPrado CM, Cushen SJ, Orsso CE, Ryan AM. Sarcopenia and cachexia in the era of obesity: clinical and nutritional impact. Proc Nutr Soc. 2016 May;75(2):188-98. doi: 10.1017/S0029665115004279. Epub 2016 Jan 8. PMID 26743210
• BACKGROUNDFord KL, Arends J, Atherton PJ, Engelen MPKJ, Goncalves TJM, Laviano A, Lobo DN, Phillips SM, Ravasco P, Deutz NEP, Prado CM. The importance of protein sources to support muscle anabolism in cancer: An expert group opinion. Clin Nutr. 2022 Jan;41(1):192-201. doi: 10.1016/j.clnu.2021.11.032. Epub 2021 Nov 29. PMID 34891022
• BACKGROUNDFord KL, Sawyer MB, Trottier CF, Ghosh S, Deutz NEP, Siervo M, Porter Starr KN, Bales CW, Disi IR, Prado CM. 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. Clin Nutr ESPEN. 2021 Feb;41:175-185. doi: 10.1016/j.clnesp.2020.11.016. Epub 2020 Dec 24. PMID 33487262