Spots Global Cancer Trial Database for Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

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Trial Identification

Brief Title: Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

Official Title: Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

Study ID: NCT05341206

Conditions

Head and Neck Neoplasms

Chemoradiotherapy

Stomatitis and Ulceration

Interventions

Herbal gargle

Normal saline

Study Description

Brief Summary: The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.

Detailed Description: Head and neck cancer accounts for about 5% of all cancers worldwide with the age-standardized incidence rate (ASIR) of HNC increased by 5.4% per year among males and 3.1% among females in Taiwan. Concurrent chemoradiotherapy (CCRT) is the most common management to treat head and neck cancer. However, CCRT may cause much side effects such as oral mucositis, radiation dermatitis, xerostomia, or infection, which influence food intake, disturb nutritional status and interrupt the course of treatment. Traditional Chinese Medicine (TCM) has been applied to treat cancer side effects for many years. Herbal gargle is composed of TCM herbals used for oral mucositis induced by chemoradiotherapy among head and neck cancer. The aim of the trial is to evaluate the effectiveness of Herbal gargle. The participants divide into two groups, treatment group and control group. The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. The control group receive normal saline 150ml for oral mucositis. The subjective questionnaires of EORTC QLQ-C30, EORTC QLQ-H\&N35 are assessed twice a week, CTCAE for grading of oral mucositis is assessed once a week, VAS is assessed everyday for 8 weeks. Besides, change of opioid dosage, body weight are also recorded. The CRP is assessed before and every week for 8 weeks and the albumin and bacteria culture are assessed before and post-treatment of 4th week and 8th week. The baseline difference of treatment and control group will be analyzed by using independent t-test and the difference of evaluation scores and blood tests between pre-treatment and post-treatment will be analyzed using multivariate logistic regression analysis. A value of P \< 0.05 will be regarded as statistically significant for the above statistical analyses.