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
Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial
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.
328 studies on the registry are indexed under Radiation Injuries; 96 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 216 interventional studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →Chulabhorn Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.
Other: Normal saline with salt/Soda
Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.
Other: Clinacanthus nutans
Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.
Other: 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
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
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
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
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
Plan to share: Yes
Ran from Feb 2016 to primary completion in Mar 2018, 25 months.
Of 69 non-industry interventional studies with no phase under Radiation Injuries, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's 25 months is below that.
Counting every sponsor, half of 72 studies reached it within 50 months; a quarter within 24 and three quarters within 116.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Chulabhorn Hospital