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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Normal saline with salt/Soda
Clinacanthus nutans
Boesenbergia rotunda
Sponsored by
Chulabhorn Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation- Induced Mucositis focused on measuring Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chulabhorn Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Normal saline with salt/Soda

Clinacanthus nutans

Boesenbergia rotunda

Arm Description

Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.

Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.

Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient satisfaction with the mouth wash
Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied

Full Information

First Posted
September 26, 2016
Last Updated
August 4, 2020
Sponsor
Chulabhorn Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03359187
Brief Title
Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
Official Title
Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulabhorn Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation- Induced Mucositis, Adverse Effect of Radiation Therapy, Head and Neck Cancer
Keywords
Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental design in 3 groups
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline with salt/Soda
Arm Type
Active Comparator
Arm Description
Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.
Arm Title
Clinacanthus nutans
Arm Type
Experimental
Arm Description
Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.
Arm Title
Boesenbergia rotunda
Arm Type
Experimental
Arm Description
Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.
Intervention Type
Other
Intervention Name(s)
Normal saline with salt/Soda
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Clinacanthus nutans
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Boesenbergia rotunda
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of mucositis grading
Description
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
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
Secondary Outcome Measure Information:
Title
Patient satisfaction with the mouth wash
Description
Scoring 1-4 not satisfied slightly satisfied moderately satisfied very satisfied
Time Frame
The last fraction of radiation therapy, through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chulabhorn Hospital
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35218685
Citation
Kongwattanakul S, Petchann N, Petroch P, Thanthong S, Tungfung S, Chamchod S, Pitiporn S, Nantajit D. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial. J Complement Integr Med. 2022 Feb 28;19(3):771-780. doi: 10.1515/jcim-2021-0457. eCollection 2022 Sep 1.
Results Reference
derived

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

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