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

Chang Gung Memorial Hospital80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms Chemoradiotherapy Stomatitis and Ulceration

Interventions

Herbal gargleDRUG

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.

Normal salineOTHER

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Willing to join the trial project and sign the informed consent form. * Age more than 20 years-old. * Pathology proved to be head and neck cancers. * Head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy. * Expected life expectancy more than 3 months. * Subjects with clear consciousness and can be assessed cooperatively. * Subjects are suitable to use Herbal gargle evaluated by Traditional Chinese medicine physicians. Exclusion Criteria: * Subjects can not sing the informed consent form. * Systemic infection. * Heart, liver and kidney insufficiency * Allergy history of Traditional Chinese medicine * Unclear conscious to use Herbal gargle.

Locations (1)

Keelung Chang Gung Memorial Hospital

Keelung, Keelung, Taiwan, Taiwan

Outcomes

Primary Outcomes

Change of CTCAE 4.0

CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy.

Time frame: change from baseline and every week for 8 weeks.

Secondary Outcomes

Change of EORTC QLQ-C30

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score, EORTC QLQ-C30, is used to measure cancer patients' physical, psychological and social functions.

Time frame: change from baseline at 4 weeks and 8 weeks post treatment.

Change of EORTC QLQ-H&N35

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head \& neck, EORTC QLQ-H\&N35, is used for assessing the health-related quality of life for head-and-neck cancer patients.

Time frame: change from baseline at 4 weeks and 8 weeks post treatment.

Change of VAS of pain of oral mucositis

Visual Analogue Scale, VAS, is used to to measure the intensity of pain of oral mucositis.

Time frame: change from baseline and everyday for 8 weeks.

Change of body weight

The oral mucositis caused by chemoradiotherapy will influence food intake. Monitor body weight provides objective evaluation of nutrition status.

Time frame: change from baseline and every week for 8 weeks.

Change of opioid use

Opioid analgesics is often prescribed for alleviating pain from oral mucositis. Monitor opioid use provides other evaluation for severity of pain and wound healing.

Time frame: change from baseline and every week for 8 weeks.

Central Contacts

Yi-Hsine Shiao, Doctor

CONTACT

24313131 vincentking44@gmail.com

Data from ClinicalTrials.gov

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