Clinical trial NCT05341206: Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
Official title: Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Chemoradiotherapy
Stomatitis and Ulceration
Keywords: Medicine, Chinese Traditional
Head and Neck Neoplasms
Chemoradiotherapy
Stomatitis and Ulceration
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group receive Herbal gargle and control group receive normal saline.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of CTCAE 4.0
timeFrame: change from baseline and every week for 8 weeks.
Secondary outcomes:
measure: Change of EORTC QLQ-C30
timeFrame: change from baseline at 4 weeks and 8 weeks post treatment.
measure: Change of EORTC QLQ-H&N35
timeFrame: change from baseline at 4 weeks and 8 weeks post treatment.
measure: Change of VAS of pain of oral mucositis
timeFrame: change from baseline and everyday for 8 weeks.
measure: Change of body weight
timeFrame: change from baseline and every week for 8 weeks.
measure: Change of opioid use
timeFrame: change from baseline and every week for 8 weeks.
measure: Change of albumin
timeFrame: change from baseline at 4 weeks and 8 weeks post treatment.
measure: Change of CRP
timeFrame: change from baseline and every week for 8 weeks.
measure: Change of common aerobic culture
timeFrame: change from baseline and every week for 8 weeks.
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
state: Keelung, Taiwan
Study officials:
References: