Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
August 4, 2020 updated by: Sirikorn Rojthamarat, Chulabhorn Hospital
Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10210
- Chulabhorn Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Normal saline with salt/Soda
Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.
|
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
|
|
EXPERIMENTAL: Clinacanthus nutans
Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.
|
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
|
|
EXPERIMENTAL: Boesenbergia rotunda
Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of mucositis grading
Time Frame: 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
|
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
Time Frame: 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
|
The last fraction of radiation therapy, through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2016
Primary Completion (ACTUAL)
March 1, 2018
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
September 26, 2016
First Submitted That Met QC Criteria
November 29, 2017
First Posted (ACTUAL)
December 2, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 4, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 004/2559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.