临床试验/CTRI/2024/05/067186

CTRI/2024/05/067186尚未招募2/3 期

Integrative approach for improving the Quality of Life of Cancer patients treated with Radiotherapy and Chemotherapy

Department of Shalya tantra Banaras Hindu University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年5月23日最近更新: 2024年5月7日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 100
试验地点: 1
主要终点: Quality of Life

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, open label, parallel group, single center trial, comparing the side effects and quality of life in Head and Neck cancer and Breast cancer patients who receive immune-modulator herbs and those who do not receive immune-modulator herbs following Radiotherapy and Chemotherapy for 6 months in 100 patients in Sir Sunderlal Hospital, Banaras Hindu University, India. The primary outcome is to assess the effects of immune-modulators on Quality of life in Head and neck and Breast cancer patients.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Histologically proven and newly diagnosed patients of Head & Neck and Breast cancer patients with no metastasis, ECOG performance scale 0-1, normal hematological, renal and hepatic parameters.

排除标准

•previously treated for any cancer and on any other alternative medicine.

结局指标

主要结局

Quality of Life

时间窗: Monthly till 6 months

次要结局

Side effects(Monthly till 6 months)

研究者

发起方

Department of Shalya tantra Banaras Hindu University

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Rashmi Gupta

IMS, BHU

研究点 (1)

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