Betina Fernanda Dambrós , Rafaela Alexia Kobus , Rafaela Caetano Horta de Lima , Alessandra Rodrigues de Camargo , Yara Maria Franco Moreno , Edson Luiz da Silva , Patricia Faria Di Pietro , Raquel Kuerten de Salles , Francilene Gracieli Kunradi Vieira
{"title":"适应冰淇淋对化疗癌症患者营养状况和口腔黏膜炎的影响：一项随机对照试验的方案研究。","authors":"Betina Fernanda Dambrós , Rafaela Alexia Kobus , Rafaela Caetano Horta de Lima , Alessandra Rodrigues de Camargo , Yara Maria Franco Moreno , Edson Luiz da Silva , Patricia Faria Di Pietro , Raquel Kuerten de Salles , Francilene Gracieli Kunradi Vieira","doi":"10.1016/j.clnesp.2025.01.037","DOIUrl":null,"url":null,"abstract":"<div><h3>Background and aims</h3><div>Chemotherapy is one of the treatments of choice for patients with hematological or head and neck neoplasms. However, chemotherapy promotes elevate occurrence of adverse events and many of them directly impact nutritional status and patients’ quality of life, which may include a low treatment tolerance. Suggested mechanisms include inflammation and oxidative stress as contributing factors to adverse effects of chemotherapy. Recently, we developed an adapted ice cream, source of protein and fiber, fat lower content, free of trans fat, gluten and lactose, one of the foods that are best accepted during chemotherapy, which have the potential of protein, cryotherapeutic and with the potential to alleviate gastrointestinal effects. The aim of this study is to develop a two-phase randomized clinical trial protocol. In this trial, the intake of an adapted ice cream will be tested during chemotherapy in adults of both sexes, with a recent diagnosis of hematological or head and neck cancer, with an indication to start chemotherapy, and who are able to take oral intake.</div></div><div><h3>Methods</h3><div>The study will be divided into two phases, with different intervention times. The adapted ice cream will be offered daily two 60 g plastic packaging (total 120 g/day), as a dessert for lunch and dinner for 21 days in phase 1 or 63-days post day one of chemotherapy in phase 2. Participants will be randomized by stratified randomization into the control (n = 26) and intervention (n = 26) groups. The primary outcomes are nutritional status and the incidence, duration, and severity of oral mucositis. Secondary outcomes are food consumption, inflammatory and oxidative stress indicators, taste disorders, and quality of life.</div></div><div><h3>Discussion</h3><div>Understanding the effect of this nutritional intervention on the outcomes we intend to analyze in this population may provide relevant information to assist with nutritional approaches during treatment. In this protocol, the methods for data collection are well based on the literature and have good validity for this population. The results of this study, whether positive or negative, will contribute to the clear scientific gap demonstrated in recent systematic reviews involving this topic.</div></div><div><h3>Registration number</h3><div>RBR-5dvnbqx in ensaiosclinicos.gov.br.</div></div>","PeriodicalId":10352,"journal":{"name":"Clinical nutrition ESPEN","volume":"66 ","pages":"Pages 160-168"},"PeriodicalIF":3.4000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of adapted ice cream on nutritional status and oral mucositis in cancer patients undergoing chemotherapy: Protocol study for a randomized controlled trial\",\"authors\":\"Betina Fernanda Dambrós , Rafaela Alexia Kobus , Rafaela Caetano Horta de Lima , Alessandra Rodrigues de Camargo , Yara Maria Franco Moreno , Edson Luiz da Silva , Patricia Faria Di Pietro , Raquel Kuerten de Salles , Francilene Gracieli Kunradi Vieira\",\"doi\":\"10.1016/j.clnesp.2025.01.037\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background and aims</h3><div>Chemotherapy is one of the treatments of choice for patients with hematological or head and neck neoplasms. However, chemotherapy promotes elevate occurrence of adverse events and many of them directly impact nutritional status and patients’ quality of life, which may include a low treatment tolerance. Suggested mechanisms include inflammation and oxidative stress as contributing factors to adverse effects of chemotherapy. Recently, we developed an adapted ice cream, source of protein and fiber, fat lower content, free of trans fat, gluten and lactose, one of the foods that are best accepted during chemotherapy, which have the potential of protein, cryotherapeutic and with the potential to alleviate gastrointestinal effects. The aim of this study is to develop a two-phase randomized clinical trial protocol. In this trial, the intake of an adapted ice cream will be tested during chemotherapy in adults of both sexes, with a recent diagnosis of hematological or head and neck cancer, with an indication to start chemotherapy, and who are able to take oral intake.</div></div><div><h3>Methods</h3><div>The study will be divided into two phases, with different intervention times. The adapted ice cream will be offered daily two 60 g plastic packaging (total 120 g/day), as a dessert for lunch and dinner for 21 days in phase 1 or 63-days post day one of chemotherapy in phase 2. Participants will be randomized by stratified randomization into the control (n = 26) and intervention (n = 26) groups. The primary outcomes are nutritional status and the incidence, duration, and severity of oral mucositis. Secondary outcomes are food consumption, inflammatory and oxidative stress indicators, taste disorders, and quality of life.</div></div><div><h3>Discussion</h3><div>Understanding the effect of this nutritional intervention on the outcomes we intend to analyze in this population may provide relevant information to assist with nutritional approaches during treatment. In this protocol, the methods for data collection are well based on the literature and have good validity for this population. The results of this study, whether positive or negative, will contribute to the clear scientific gap demonstrated in recent systematic reviews involving this topic.</div></div><div><h3>Registration number</h3><div>RBR-5dvnbqx in ensaiosclinicos.gov.br.</div></div>\",\"PeriodicalId\":10352,\"journal\":{\"name\":\"Clinical nutrition ESPEN\",\"volume\":\"66 \",\"pages\":\"Pages 160-168\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical nutrition ESPEN\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2405457725000385\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"NUTRITION & DIETETICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical nutrition ESPEN","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405457725000385","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/23 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
Effect of adapted ice cream on nutritional status and oral mucositis in cancer patients undergoing chemotherapy: Protocol study for a randomized controlled trial
Background and aims
Chemotherapy is one of the treatments of choice for patients with hematological or head and neck neoplasms. However, chemotherapy promotes elevate occurrence of adverse events and many of them directly impact nutritional status and patients’ quality of life, which may include a low treatment tolerance. Suggested mechanisms include inflammation and oxidative stress as contributing factors to adverse effects of chemotherapy. Recently, we developed an adapted ice cream, source of protein and fiber, fat lower content, free of trans fat, gluten and lactose, one of the foods that are best accepted during chemotherapy, which have the potential of protein, cryotherapeutic and with the potential to alleviate gastrointestinal effects. The aim of this study is to develop a two-phase randomized clinical trial protocol. In this trial, the intake of an adapted ice cream will be tested during chemotherapy in adults of both sexes, with a recent diagnosis of hematological or head and neck cancer, with an indication to start chemotherapy, and who are able to take oral intake.
Methods
The study will be divided into two phases, with different intervention times. The adapted ice cream will be offered daily two 60 g plastic packaging (total 120 g/day), as a dessert for lunch and dinner for 21 days in phase 1 or 63-days post day one of chemotherapy in phase 2. Participants will be randomized by stratified randomization into the control (n = 26) and intervention (n = 26) groups. The primary outcomes are nutritional status and the incidence, duration, and severity of oral mucositis. Secondary outcomes are food consumption, inflammatory and oxidative stress indicators, taste disorders, and quality of life.
Discussion
Understanding the effect of this nutritional intervention on the outcomes we intend to analyze in this population may provide relevant information to assist with nutritional approaches during treatment. In this protocol, the methods for data collection are well based on the literature and have good validity for this population. The results of this study, whether positive or negative, will contribute to the clear scientific gap demonstrated in recent systematic reviews involving this topic.
期刊介绍：
Clinical Nutrition ESPEN is an electronic-only journal and is an official publication of the European Society for Clinical Nutrition and Metabolism (ESPEN). Nutrition and nutritional care have gained wide clinical and scientific interest during the past decades. The increasing knowledge of metabolic disturbances and nutritional assessment in chronic and acute diseases has stimulated rapid advances in design, development and clinical application of nutritional support. The aims of ESPEN are to encourage the rapid diffusion of knowledge and its application in the field of clinical nutrition and metabolism. Published bimonthly, Clinical Nutrition ESPEN focuses on publishing articles on the relationship between nutrition and disease in the setting of basic science and clinical practice. Clinical Nutrition ESPEN is available to all members of ESPEN and to all subscribers of Clinical Nutrition.
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