CTRI/2026/02/102654尚未招募不适用
A Randomized double blinded placebo-controlled Trial Evaluating the Efficacy of Oral Glutathione and Vitamin C in Preventing Chemotherapy-Induced Oral Mucositis in Cancer Patients (GLOMUC Trial)
Dr LP Bhaskar Bhuvan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Oral mucositis (OM) is a common, debilitating complication in cancer patients receiving chemotherapy, especially with 5-fluorouracil (5-FU) or anthracycline-based regimens. OM manifests as painful ulcerations, increasing infection risk, causing nutritional compromise, and interrupting cancer treatment. Standard preventive measures exist, but are not effective for all regimens. Evidence suggests that oxidative stress contributes to OM pathogenesis, and antioxidants like glutathione, supported by vitamin C, may reduce its severity. Real world experience from our institute indicate that glutathione combined with vitamin C (GC) supplementation can lower OM grade/severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18-60 years.2.Patients should receive intravenous cancer chemotherapy neoadjuvant, adjuvant, and palliative intent.
- •Chemotherapy should be anthracycline, infusional 5 FU.
- •Patients should have CTCAE v 6 grade 2 and above OM on day 5.
- •Should have adequate renal and liver functions.
- •Patients should have an adequate bone marrow function with Haemoglobin (greater than) 8g/dl, Total Leukocyte count (greater than) 4000/mm3, platelet count of (greater than)1.5 lac/mm3 prior to chemotherapy.
- •Patient should be verbally communicating and willing to give the response.
- •Patient performance status to be ECOG 0 or 1.
- •Patients should be able to take orally.
- •Patient has a predicted life expectancy of (greater or equal to)6 months.
排除标准
- •1.Patients who are not compliance with tablet medication.
- •Patient who are dependent on Feeding jejunostomy, or Total Parenteral Nutrition and not able to take orally.
- •Patients who are either HBSAg, HCV, or HIV positive patients.
- •Patients who are on oral metronomic chemotherapy or targeted therapy.
- •Patients who are on concurrent radiation treatment.
- •Patient is pregnant or breast feeding.
- •(Females of childbearing potential are require having a negative urine pregnancy test prior to entering the study.).
- •Patient having poor social support.
- •SGOT (AST) (greater than) 2.0 x upper limit of normal (ULN) and SGPT (ALT) (greater than)2.0 x ULN and Bilirubin (greater than)1.5 x ULN and Serum creatinine (greater than) UL.
- •Patients with history active tuberculosis or active fungal infections or oral thrush, dental infections, allergic bronchial asthma.
- •Patients with history of leucoplakia, erythroplakia, oral cavity cancers, non-healing ulcers in the oral cavity.
- •Patients with history of coronary artery disease with left ventricle ejection fraction less than 55% or cardiac conduction abnormalities.
- •Active smoking and alcohol intake (should be stopped with in last 3 months).
- •Patients with acute or chronic liver disease and kidney disease.
研究者
Dr L P Bhaskar bhuvan
HCGCC
研究点 (1)
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