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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline with salt/Soda | Active Comparator | Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml. |
|
| Clinacanthus nutans | Experimental | Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml. |
|
| Boesenbergia rotunda | Experimental | Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with the mouth wash | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulabhorn Hospital | Bangkok | 10210 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218685 | Derived | 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. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Experimental design in 3 groups
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| 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 |
|