Tolerance to Immunomodulatory Nutritional Therapy in Oncology Patients Undergoing Chemotherapy and Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Adherence to the immunomodulatory nutritional supplementation regimen
研究概览
简要总结
The importance of nutritional support is established in some types of neoplasms, especially those involving the digestive tract. Recently, nutritional supplements containing substances with proposed immunomodulatory action have been developed. It is still unclear whether the use of immunomodulatory supplements can reduce the occurrence of treatment-related toxicities in oncology, such as radiodermatitis and mucositis. The aim of this study is to investigate whether the use of supplements with immunomodulatory action could reduce the occurrence of cutaneous and mucosal toxicities in oncology treatment, such as radiodermatitis and diarrhea.
详细描述
A prospective pilot study will be conducted to assess the use of immunomodulatory nutritional therapy in patients undergoing chemotherapy and radiotherapy for adjuvant or definitive cancer treatment at a service affiliated with Oncologia D'Or or at the Instituto do Câncer do Estado de São Paulo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of carcinoma from one of the following two primary sites: breast (Cohort A); anal canal (Cohort B);
- •Localized disease, stages I-III, according to the 8th edition of TNM classification;
- •Indication for neoadjuvant TC-HP treatment, surgery, and adjuvant radiotherapy for breast cancer (Cohort A) or definitive chemoradiotherapy for anal canal cancer (Cohort B).
排除标准
- •Metastatic disease;
- •Inability to intake food orally;
- •Conditions that compromise the ability to ingest or absorb nutritional therapy, such as inflammatory bowel disease, intestinal perforation, intestinal obstruction, or uncontrolled lower gastrointestinal bleeding;
- •Previous radiotherapy in the same field where the current treatment will be performed.
结局指标
主要结局
Adherence to the immunomodulatory nutritional supplementation regimen
时间窗: Up to 36 weeks
Percentage of adherence to the immunomodulatory nutritional supplementation regimen
次要结局
未报告次要终点
研究者
Camila Motta Venchiarutti Moniz
Doctor, Principal Investigator
D'Or Institute for Research and Education