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Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).
Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.
90 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).
Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thyme honey | Experimental | oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017) |
|
| Saline | Active Comparator | oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thyme honey mouth rinse | Drug | oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017) |
| Measure | Description | Time Frame |
|---|---|---|
| subjective dry mouth score | Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints. | change from baseline at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| objective dry mouth score | Objective dry mouth score: The patients will be examined for their signs of dry mouth including: (Osailan et al., 2011).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Seif, professor | faculty of dentistry- Ain Shams university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of dentistry- Ain shams university | Cairo | Egypt |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| saline mouth rinse | Drug | saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy |
|
| change from baseline at 4 weeks |
| salivary PH | identification of PH according to the color of the PH paper | change from baseline at 4 weeks |
| nitric oxide levels | assessment of nitric oxide levels in the salivary samples using ELISA | change from baseline at 4 weeks |
| Salivary flow rate | assessing unstimulated salivary flow rate in 5 minutes | change from baseline at 4 weeks |