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临床试验/CTRI/2025/02/080769
CTRI/2025/02/080769尚未招募不适用

Impact of sarcopenia on oncological outcomes in oral cavity squamous cell carcinoma patients undergoing surgery An ambispective study

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
299
试验地点
1
主要终点
Morbidity which may be surgical Surgical Site Infection Wound Dehiscence

研究概览

简要总结

Oral Squamous Cell Carcinoma has a very high incidence in India. Despite major advances in the treatment modalities over the past few decades, the overall survival rates have not changed dramatically. Although there aren’t many modifiable risk factors before treatment, sarcopenia has the potential to be a predictive and prognostic factor for patients with head and neck cancer . Identifying patients who may not respond well to their treatment could aid in its modification and guide further research in these higher-risk populations. This study aims to examine the impact of sarcopenia on postoperative outcomes, its association with obesity and blood parameters, and its influence on radiation-induced toxicity and quality of life in patients who have undergone surgery with or without PORT. As sarcopenia involves both muscle mass and function loss, it is essential to evaluate these parameters comprehensively—an area less extensively studied in head and neck cancer patients. Given that sarcopenia’s cutoff values differ by geographic region, race, sex, and age, establishing reference values specific to this region is crucial.

An ambispective analysis will be conducted at a tertiary cancer care centre over a period of 2 years. All patients with oral cancer who have been treated or planned to be treated primarily by surgery and are satisfying the inclusion and exclusion criteria will be included in the study. The patient details, height, weight, BMI, blood parameters, HPE , clinical - radiological reports will be retrieved from the medical records department to ascertain eligibility and the pre-operative CT scans will be retrieved from the department of radiology,for the retrospective group of patients. For the prospective group patient, patient details , height, weight, BMI, will be taken preoper preopratively within 3 months of surgery. Preoperative scans will be done . Muscle function will be assessed preoperatively by hand grip test, chair test, gait test. The date and type of surgery will be recorded. The postoperative period will be reviewed with the records and with the patients for any complications. The patients in the retrospective group will be called to follow up whereas the patients in the prospective group will be followed up as per NCCN follow-up protocol. They will be followed up every month for the first year and every 2nd month for the second year. Thereafter, follow-up will be scheduled every 6 months till the 5th year and once a year after that. The Quality of Life (QoL) will be assessed using previously validated questionnaires (SARC-F). The patient who has received PORT will be assessed for short-term and long-term radiation toxicity using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and criteria of Radiation Therapy Oncology Group (RTOG).

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Histologically proven Squamous Cell Carcinoma Site Oral Cavity Subsites Lip tongue the floor of the mouth buccal mucosa hard palate retromolar trigone gingivo alveolar complex Stage I IV M0 according to AJCC 8th edition Treated primarily by adequate surgery at AIIMS or NCI from January 2022 till the date of thesis submission All patients who have a follow up of at least 6 months from the date of the last adjuvant therapy Patients with ECOG Performance Status 0 to 2.

排除标准

  • Non-squamous histology Any distant metastasis History of any previous malignancy in the past 5 years Patient ASA more than 2 History of any therapeutic irradiation to the head and neck region Patients with Poor Performance Status of 3 or more.

结局指标

主要结局

Morbidity which may be surgical Surgical Site Infection Wound Dehiscence

时间窗: 30 days after post surgery

Hematoma Salivary Leak Chyle Leak Flap Necrosis or medical conditions which

时间窗: 30 days after post surgery

may prolong hospital stay or lead to readmissions

时间窗: 30 days after post surgery

次要结局

  • to assess overall survival, disease free survival,sii, h-index,nlr,obesity, radiation toxicity(upto 2 years post surgery)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rosy Saikia

All India Institute Of Medical Sciences

研究点 (1)

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