Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy

Study Overview
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Brief Summary
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Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

Detailed Description
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To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.

Official Title
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Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial

Conditions
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Adverse Effect of Radiation Therapy, Head and Neck Cancer, Radiation- Induced Mucositis

Intervention / Treatment
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* Other: Normal saline with salt/Soda
* Other: Clinacanthus nutans
* Other: Boesenbergia rotunda


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 15 years old or older, Diagnosed with Head and Neck cancer On treatment of external Radiation therapy Exclusion Criteria: Pregnant Previously underwent external Radiation therapy Illiterate

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental design in 3 groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal saline with salt/Soda<br>Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml. | Other: Normal saline with salt/Soda<br>* Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment<br>|
| Experimental: Clinacanthus nutans<br>Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml. | Other: Clinacanthus nutans<br>* Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment<br>|
| Experimental: Boesenbergia rotunda<br>Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml. | Other: Boesenbergia rotunda<br>* Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mucositis grading | RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible | Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the mouth wash | Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied | The last fraction of radiation therapy, through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect