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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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 | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal gargle | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of CTCAE 4.0 | CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy. | change from baseline and every week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline at 4 weeks and 8 weeks post treatment. |
| Change of EORTC QLQ-H&N35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Hsine Shiao, Doctor | Contact | 24313131 | 2777 | vincentking44@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | Keelung, Taiwan | 20401 | Taiwan |
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The treatment group receive Herbal gargle and control group receive normal saline.
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The color of Herbal gargle is yellowish while normal saline is transparent. Therefore, the study belongs to open label trial.
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| Normal saline | 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. |
|
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. |
| 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. | 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. | 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. | change from baseline and every week for 8 weeks. |
| Change of albumin | Albumin has been used as maker of nutrition status. | change from baseline at 4 weeks and 8 weeks post treatment. |
| Change of CRP | C-reactive protein is used to monitor severity of oral mucositis. | change from baseline and every week for 8 weeks. |
| Change of common aerobic culture | Aerobic culture is used to monitor the change of bacteria flora before and after Herbal gargle treatment. | change from baseline and every week for 8 weeks. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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