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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Head and Neck Neoplasms Chemoradiotherapy Stomatitis and Ulceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The treatment group receive Herbal gargle and control group receive normal saline.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The color of Herbal gargle is yellowish while normal saline is transparent. Therefore, the study belongs to open label trial.

Study Groups

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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.

Group Type EXPERIMENTAL

Herbal gargle

Intervention Type DRUG

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.

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.

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type OTHER

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

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No