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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341206
• Other study ID #: 202101017A3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Hsine Shiao, Doctor
• Phone: 24313131
• Email: vincentking44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemoradiotherapy
• Head and Neck Neoplasms
• Mucositis
• Stomatitis
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung	Keelung, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.	change from baseline at 4 weeks and 8 weeks post treatment.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Change of albumin	Albumin has been used as maker of nutrition status.	change from baseline at 4 weeks and 8 weeks post treatment.
Secondary	Change of CRP	C-reactive protein is used to monitor severity of oral mucositis.	change from baseline and every week for 8 weeks.
Secondary	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.