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NCT03359187 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03359187
Other study ID # 004/2559
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date March 2018

Study information
Verified date August 2020
Source Chulabhorn Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Normal saline with salt/Soda
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
• Clinacanthus nutans
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
• Boesenbergia rotunda
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

Locations
Country Name City State
Thailand Chulabhorn Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulabhorn Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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