Nutritional Supplement Ocoxin® Combined with Gemcitabine-Based Chemotherapy in Patients with Advanced Pancreatic Adenocarcinoma  

作　　者：Mayté Lima-Pérez Jorge Luis Soriano-García Masiel González-Meisozo Jorge Luis Soriano-Lorenzo Vilma Fleites-Calvo Dunia Morales-Morgado Carlos Domínguez-Álvarez Iván Ramón-Concepción Raidel Rodríguez-Barrios Alicia Tarinas-Reyes Ivis Mendoza-Hernández Rolando Uranga-Piña Mayté Lima-Pérez;Jorge Luis Soriano-García;Masiel González-Meisozo;Jorge Luis Soriano-Lorenzo;Vilma Fleites-Calvo;Dunia Morales-Morgado;Carlos Domínguez-Álvarez;Iván Ramón-Concepción;Raidel Rodríguez-Barrios;Alicia Tarinas-Reyes;Ivis Mendoza-Hernández;Rolando Uranga-Piña(Clinical Oncology Department, Ameijeiras Hospital, Havana, Cuba;Clinical Pathology Department, Ameijeiras Hospital, Havana, Cuba;Clinical Section, National Coordinating Centre for Clinical Trials, Havana, Cuba;Biostatistics Section, National Coordinating Centre for Clinical Trials, Havana, Cuba)

机构地区：[1]Clinical Oncology Department, Ameijeiras Hospital, Havana, Cuba [2]Clinical Pathology Department, Ameijeiras Hospital, Havana, Cuba [3]Clinical Section, National Coordinating Centre for Clinical Trials, Havana, Cuba [4]Biostatistics Section, National Coordinating Centre for Clinical Trials, Havana, Cuba

出　　处：《Open Journal of Gastroenterology》2024年第8期267-287,共21页肠胃病学期刊（英文）

摘　　要：Background: the quality of life (QoL) of patients with pancreatic ductal adenocarcinoma (PDAC), with its limited survival, can be affected by chemotherapy-induced toxicity. The main objective was to evaluate the effect of introducing ocoxin oral solution (OOS) in combination with standard therapy on quality of life. Methods: Thirty patients were enrolled in an exploratory, prospective, single-centre clinical trial in the oncology department of “Hermanos Ameijeiras” University Hospital in Havana, Cuba. Quality of life was measured using the EORTC QLQ-C30 questionnaire and toxicity was assessed using the NCI-CTC-AE classification version 5.0. Results: There was stability in the scores over time for overall QoL and the functional scale criteria, while in terms of symptoms, fatigue, pain and loss of appetite were reduced. No grade 3 - 4 adverse events (AEs) were recorded, and only 14.9% of toxicities were classified as grade 2, and these were considered to be unrelated to OOS. Biochemical and nutritional parameters were normalised at 12 months compared to the baseline values. Conclusions: This clinical study is the first report of the use of OOS in patients with advanced pancreatic cancer, and demonstrates that it is able to maintain optimal quality of life with reduced severity of toxicity during and after combination treatment with gemcitabine-based chemotherapy.Background: the quality of life (QoL) of patients with pancreatic ductal adenocarcinoma (PDAC), with its limited survival, can be affected by chemotherapy-induced toxicity. The main objective was to evaluate the effect of introducing ocoxin oral solution (OOS) in combination with standard therapy on quality of life. Methods: Thirty patients were enrolled in an exploratory, prospective, single-centre clinical trial in the oncology department of “Hermanos Ameijeiras” University Hospital in Havana, Cuba. Quality of life was measured using the EORTC QLQ-C30 questionnaire and toxicity was assessed using the NCI-CTC-AE classification version 5.0. Results: There was stability in the scores over time for overall QoL and the functional scale criteria, while in terms of symptoms, fatigue, pain and loss of appetite were reduced. No grade 3 - 4 adverse events (AEs) were recorded, and only 14.9% of toxicities were classified as grade 2, and these were considered to be unrelated to OOS. Biochemical and nutritional parameters were normalised at 12 months compared to the baseline values. Conclusions: This clinical study is the first report of the use of OOS in patients with advanced pancreatic cancer, and demonstrates that it is able to maintain optimal quality of life with reduced severity of toxicity during and after combination treatment with gemcitabine-based chemotherapy.

关 键 词：EORTC QLQ-C30 Ocoxin CHEMOTHERAPY Pancreatic Cancer Quality of Life 

分 类 号：R73[医药卫生—肿瘤]