Effect of high protein nutritional supplementation on nutritional status, physical function and quality of life in elderly patients with stomach cancer receiving neoadjuvant chemotherapy

This interventional prospective randomized controlled study was conducted to compare the effects of high protein oral nutritional supplement (ONS) and medical nutritional therapy to medical nutrition therapy alone on nutritional status, quality of life and physical function capacity after neoadjuvant chemotherapy (CT) in patients aged 65 and over with newly diagnosed newly diagnosed locally advanced gastric cancer. Between February 2023 and February 2024, 46 patients consisting of 9 males and 37 females, with newly diagnosed locally advance gastric cancer aged 65 and over who were started on neoadjuvant CT and were admitted to the Medical Oncology outpatient clinic at Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital randomized to two groups. One group received ONS and medical nutrition therapy (n=23) and other group received only standard nutrition therapy (n=23) for eight weeks and their nutritional status, physical function capacity and quality of life were evaluated. Patients were referred to a dietitian by the physician. The results of the patients' hand grip strength and anthropometric measurements, body composition analyzes and some biochemical parameters were recorded at the beginning and end of the study. Three-day food consumption records were taken at the beginning, middle and end of the study. An ONS follow-up form was administred every two weeks to monitor ONS consumption. Mini Nutritional Assessment (MNA) was used to assess nutritional status, Activities of Daily Living Scale (ADL) and Instrumental Activities of Daily Living Scale (IADL) were used to determine physical function capacity, European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) was used to determine quality of life, and to assess farilty status G8 was used. According to the food consumption records of the patients who participated in the study, it was found that the daily energy and macronutrient intake of all patients who received ONS and those who did not receive ONS at the 4th and 8th weeks were higher compared to the beginning of the study. However, the amount of energy, protein and carbohydrate intake of patients receiving ONS was higher than that of patients not receiving ONS. Dietary micronutrient intake of patients receiving ONS was found to be statistically higher in the 4th week compared to the beginning of the study (p<0.05). Vitamin E, vitamin C, thiamine, riboflavin, niacin, folate, sodium, potassium, magnesium, iron, iron and omega 3 were found to be statistically higher in male patients receiving ONS compared to male patients not receiving ONS at the 4th and 8th weeks (p<0.05). A significant increase in MNA scores was found in the study period in all groups except female patients who did not receive ONS (p<0.05). There was no significant difference in MNA scores between male and female patients receiving ONS and those not receiving ONS (p>0.05). It was found that there was no significant difference in the ADL and IADL scores of patients who received ONS and those who did not receive ONS at the beginning and end of the study period (p>0.05). According to EORTC QLQ-C30, only the constipation rate was found to be significantly higher in the group not receiving ONS than in the group receiving ONS (p<0.05). While there was no significant difference between the group receiving ONS and the group not receiving ONS at the end of the study compared to the beginning of the study in the subscales of labor function, dyspnea, loss of appetite and diarrhea from the EORTC QLQ-C30 scale (p>0.05), it was found to be statistically lower in the subscales of general health status, physical function, emotional function, cognitive function and social function (p<0.05). Fatigue, nausea and vomiting, pain, constipation and financial difficulty subscales were found to be significantly higher (p<0.05). It was found that there was no significant difference in both genders at the end of the study in the group receiving ONS compared to the beginning of the study (p>0.05). At the end of the study in the group not receiving ONS, upper mıddle arm circumference was not significantly different in female patients (p>0.05) but significantly lower in male patients (p<0.001). When the difference between the groups was examined, it was found that there was no significant difference in both genders both at the beginning and at the end of the study (p>0.05). In the group receiving ONS, while there was no significant difference in the hand grip strength of female patients at the end of the study compared to the beginning of the study (p>0.05), it was found to be significantly higher in male patients (p=0.029). While there was no significant difference in the hand grip strength of the group not receiving ONS at the end of the study compared to the beginning of the study, it was found to be significantly lower in male patients (p>0.002). When the differences between the groups were analyzed, there was no significant difference between male patients who received ONS and those who did not receive ONS at the beginning and at the end of the study (p>0.05), it was found to be significantly higher in female patients who received ONS (p<0.05). According to the Charlson comorbidity index, the majority of patients (73.9%) had mild comorbidity and 26.1% had no comorbidity. There was no statistical difference between the groups according to comorbidity scores (p>0.05). No patient had severe (>2) comorbidity. At the end of the study, there was a statistical increase in the G8 scores of the ONS and non-ONS groups compared to the baseline (p<0.05). There was no statistical difference between the G8 scores of the ONS and non-ONS groups at the beginning and end of the study (p>0.05). In conclusion, our study demonstrated that ONS support with high-protein improved the nutritional status of older patients with gastric cancer receiving CT, but there was no significant change in functional capacity and quality of life scales. However, studies with longer follow-up and larger sample sizes are needed to observe the effect of a high-protein diet in older patients with gastric cancer. Keywords: Gastric cancer, oral nutritional supplement, nutritional status, physical function, quality of life.