2021-01 Vladimir Lyadov

Project:    

Prehabilitation in sarcopenic patients with resectable gastro-intestinal tumours

Funding:

377 000 rubles

Brief Description:

Gastrointestinal (GI) tumors (of esophagus, stomach, pancreas, liver, colon) represent a significant medical and social problem. The incidence of liver, bile ducts, colon cancers is growing rapidly in Russia. Despite the fact that GI tumors account for a little more than 20% of all cancer cases, more than 30% of all deaths in the world and in Russia are due to this group of diseases.

Sarcopenia, or skeletal muscle depletion, is diagnosed in more than a half of patients with advanced GI tumors at the start of treatment, which is explained by a combination of nutritional deficiency and metabolic rearrangement, as well as the release of proinflammatory cytokines by tumor cells. The phenomenon of sarcopenia is currently considered the leading component of cancer cachexia syndrome and is easily diagnosed by the analysis of CT scans.

Such variations in the patient’s body composition as sarcopenic obesity and myosteatosis (accumulation of adipose tissue in skeletal muscles) are of clinical importance. In general, the high incidence of sarcopenia and nutritional deficiencies, as well as the complex nature of surgical interventions for GI tumors, led to the development of the concept of “pre-rehabilitation”. The concept of “pre-rehabilitation” means preparing patients for anticancer treatment (surgical or combined) using a combination of three components: exercise therapy, nutritional and psychological support. The duration of such programs usually ranges from 14 to 28 days.

Currently, neither international nor Russian publications contain detailed and clinically validated pre-rehabilitation programs. In addition, there is a lack of high-quality data to support the safety and efficacy of such a labor-intensive and costly approach to patient preparation. No risk groups have been identified that would improve the results of the introduction of pre-rehabilitation into practice due to targeted use in the most vulnerable patient population.

Therefore, we have developed a staged prospective clinical study with the aim to assess the possibility of introducing a structured pre-rehabilitation program into the complex management of patients with resectable GI tumors. At the first stage, we plan to identify a risk group for the development of unfavorable immediate results of surgical treatment in patients with resectable forms of GI tumors and to assess the relationship of the functional state of patients, changes in body composition, and psychological status with the treatment outcomes.

Further, it is planned to conduct a pilot phase I study in order to assess the safety of the developed pre-rehabilitation program for patients. After the successful implementation of the first two stages, a phase II randomized controlled trial will be conducted to assess the safety and efficacy of the developed pre-rehabilitation program in patients with gastrointestinal tumors belonging to the selected risk group.