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临床试验/CTRI/2024/08/072096
CTRI/2024/08/072096尚未招募Phase 3 4

Role of nutritional therapy in oral squamous cell carcinoma patients in improving nutritional indices- a prospective study

Rajah Shaikh1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
77
试验地点
1
主要终点
Measuring the improvement in nutritional indices and overall health via questionnaires and nutritional indices

研究概览

简要总结

Cancer-related malnutrition is an often overlooked and undertreated symptom in cancer-affected patients despite approximately 10-20% of deaths occurring from malnutrition in cancer suffering patients. Various body measurements have been used to diagnose malnutrition and concomitant sarcopenia. Nutritional indices have been shown to have prognostic value in various types of cancer. in this study, we want to assess the of nutritional indices in patients suffering from oral squamous cell carcinoma and the role of nutritional therapy following treatment. We will achieve this by performing a preoperative nutritional assessment using questionnaires (Scored Patient-Generated Subjective Global Assessment (PG-SGA)), anthropometric measurements and nutritional indices (PNI, NRI, SII) (calculated using serum albumin, peripheral blood samples, and the previously measured anthropometric data), we will also check for serum albumin and C-reactive protein levels pre-treatment. Post treatment, participants will be provided with a nutritional regimen and appropriate oral nutritional supplements (ONS). There will be two follow-ups, at 3 months and 6 months, where the assessments will be done in a similar manner as preoperatively. Additionally, clinical interview will be conducted and additional questionnaires (the head and neck symptom checklist and EORTC QLQ C30) will be administered to assess quality of life. The results will provide us with insight on the role of nutritional therapy in improving prognostic nutritional indices post oral squamous cell carcinoma treatment. The study will take place over a course of 2 and half years, with the participants being chosen from among the patients reporting to the Zulekha Yenepoya Institute of Oncology by simple random sampling.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients newly diagnosed with primary oral squamous cell carcinoma Patients with operable Oral Squamous Cell Carcinoma in any subsite.

排除标准

  • Patients with previous history of having undergone oral squamous cell carcinoma treatment Patients with recurrent oral cancer Patients with systemic comorbidities.
  • Patients with oral submucous fibrosis stage 2,3,4 (Haider et al classification) Patients with proven distant metastasis.

结局指标

主要结局

Measuring the improvement in nutritional indices and overall health via questionnaires and nutritional indices

时间窗: At diagnosis, immediately after intervention, at 6 months post intervention, nd 1 yr post intervention

次要结局

  • improvement in quality of life(1 year)

研究者

发起方
Rajah Shaikh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rajah Shaikh

yenepoya dental college

研究点 (1)

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