Adverse Effect of Radiation Therapy, Head and Neck Cancer, Radiation- Induced Mucositis
Conditions
Keywords
Radiation- induced mucositis, Head and Neck Cancer, Radiation therapy side effect
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.
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
Sponsors
Chulabhorn Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Experimental design in 3 groups
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
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
* Pregnant * Previously underwent external Radiation therapy * Illiterate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of mucositis grading | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with the mouth wash | 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 |
Countries
Thailand
Outcome results
None listed