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CompletedNCT03359187Updated Aug 5, 2020

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

An interventional study of Normal saline with salt/Soda and Clinacanthus nutans in Radiation- Induced Mucositis, Adverse Effect of Radiation Therapy and Head and Neck Cancer, sponsored by Chulabhorn Hospital. Completed at 1 site in Thailand. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Chulabhorn Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
15 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Radiation- induced mucositis
  • Head and Neck Cancer
  • Radiation therapy side effect
03

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 15 years old or older,
  • Diagnosed with Head and Neck cancer
  • On treatment of external Radiation therapy

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Previously underwent external Radiation therapy
  • Illiterate
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Normal saline with salt/Soda

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

    Other: Normal saline with salt/Soda

  • Experimental
    Clinacanthus nutans

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

    Other: Clinacanthus nutans

  • Experimental
    Boesenbergia rotunda

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

    Other: Boesenbergia rotunda

Interventions

  • OtherNormal 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

  • OtherClinacanthus 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

  • OtherBoesenbergia 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

05

What researchers measure

Primary outcomes

  1. 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

    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 outcomes

  1. Patient satisfaction with the mouth wash

    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

06

Study locations

1 site
  • Chulabhorn Hospital
    Bangkok, 10210, Thailand
07

References and documents

Publications

  • 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. PubMed 35218685 ↗

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT03359187
Lead sponsor
Chulabhorn Hospital
Responsible party
Sirikorn Rojthamarat (Principle Investigator, Chulabhorn Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
Feb 2016
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Aug 5, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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