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NCT Number: NCT03359187

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

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

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Key information

Conditions

Radiation- Induced Mucositis Adverse Effect of Radiation Therapy Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Wounds and Injuries

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulabhorn Hospital

Bangkok, 10210, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal saline with salt/Soda

Other

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

Other

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

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chulabhorn Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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