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Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
Study Purpose
The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head & neck cancer patients.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: Treatment 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.
Sham Comparator: Control group
The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
Interventions
Drug: - Herbal gargle
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.
Other: - Normal saline
The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
Contact a Trial Team
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International Sites
Status
Address
Keelung Chang Gung Memorial Hospital
Keelung, Keelung, Taiwan, 20401
Site Contact
Yi-Hsine Shiao, Doctor
[email protected]
24313131 #2777
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