The effect of Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer-induced cachexia: study protocol for a randomized clinical trial.

Background: Current dietary strategies to manage cancer cachexia and the relevant outcomes did not provide a comprehensive solution. This study will evaluate the effect of a Mediterranean diet on inflammatory markers, nutritional status, muscle mass, and strength among patients with cancer cachexia (CC).

Methods: This will be a randomized clinical trial involving men and women diagnosed with localized or advanced colorectal cancer-induced cachexia. In total, 40 patients with CC will be recruited based on inclusion criteria and then these patients will be randomly allocated to receive either a Mediterranean diet (n = 20) or only routine nutritional advice (n = 20) for 8 weeks. The primary outcome will be nutritional status, muscle mass and strength, and serum concentrations of inflammatory markers including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and high-sensitive C-reactive protein (hs-CRP). Moreover, we will consider serum albumin and total protein levels, complete blood count (CBC), and quality of life as the secondary outcomes. All outcomes will be measured at the beginning and end (the eighth week) of the study. We will assess participants' adherence to the prescribed diets by using a 1-day food record in the second, fourth, sixth, and eighth weeks of the study.

Discussion: Along with adequate calorie and protein intake in cancer cachexia, reducing inflammatory cytokines might be a useful strategy for maintaining nutritional status and body composition. Mediterranean diet has been shown to have anti-inflammatory properties, and by its components, it might help patients with cachexia to have a better nutritional status and quality of life.

Trial Registration: Iranian Registry of Clinical Trials ( www.irct.ir ) RCT20211027052884N1. Prospectively registered on November 09, 2021.