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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Radiation- Induced Mucositis; Adverse Effect of Radiation Therapy
• Interventions: Other: Boesenbergia rotunda; Other: Normal saline with salt/Soda; Other: Clinacanthus nutans

• Registration Number: NCT03359187
• Lead Sponsor: Chulabhorn Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-02
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boesenbergia rotunda	Boesenbergia rotunda	Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.
Normal saline with salt/Soda	Normal saline with salt/Soda	Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.
Clinacanthus nutans	Clinacanthus nutans	Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.

Primary Outcome Measures

Name	Time	Method
Change of mucositis grading	Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chulabhorn Hospital; 🇹🇭 Bangkok, Thailand