Clinical Data

Caphosol is clinically proven to reduce the impact of oral mucositis¹⁵

Twice as many patients remain free from Oral Mucositis with Caphosol.
The Papas randomised controlled trial showed more people in the Caphosol group remained free from Oral Mucositis compared with control (40%:19% respectively; this endpoint was not statistically tested.)	% patients with no mucositis
Reduced severity and duration of Oral Mucositis compared with controls
Peak National Institute of Dental and Craniofacial Research score 1.0 vs. 3.0; p=0.004. Duration 3.72 versus 7.20 days; p=0.00096.	severity of Oral Mucositis
Patients taking Caphosol experienced: Less severe oral mucositis-associated pain compared with controls
Peak pain level 19.8 vs 50.33; p<0.0001 Duration 2.86 vs 7.67 days; p<0.001 *peak pain was a variable rank score based upon patient judgement.	Severity of pain
Patients taking Caphosol experienced: Reduced need for morphine-based pain management compared with controls
34.54mg vs 122.78mg; p=0.0001. Duration 1.26 days vs 4.02 days; p=0.0003	Morphine use

This randomised controlled trial comparing Caphosol to standard care (fluoride rinse), as well as supporting studies, show that the use of Caphosol consistently:

• Reduces the number of patients who develop oral mucositis
• Resolves oral mucositis faster
• Reduces the need for pain relief
• Reduces the severity of oral mucositis overall
• Reduced frequency of percutaneous endoscopic gastrotomy (PEG)¹⁶
• Reduced need for hospitalisation¹⁶
• Less morphine use¹⁵

Reduction of painful oral mucositis by supersaturated calcium phosphateoral rinse in head and neck cancer patients receiving chemotherapy and radiation³⁴

Overview

This open-label observational study provides information from a registry database of cancer patients receiving chemotherapy or radiotherapy who have received treatment with Caphosol. The registry analysed the effects of Caphosol in head and neck cancer patients along with the frequency of patient dosing, adherence to treatment, and patient and physician global satisfaction assessments.

Method

The effects of Caphosol on oral mucositis in head and neck cancer patients were evaluated using an open-label observational registry. Patients at risk of oral mucositis were given Caphosol and instructed to rinse 4-10 times daily depending on the severity of the mucositis. Patients and physicians completed questionnaires on the symptoms of oral mucositis and severity was scored according to National Cancer Institute toxicity scales. Global satisfaction assessments were also carried out.

Results

Low rates of oral mucositis was seen in patients with head and neck cancer treated with Caphosol:

• 49% of patients experienced OM of grade ≤1, with only one patient (2%) experiencing grade 4 severity
• 44% of patients experienced oral pain of grade ≤1 and 39% of patients experienced dyphagia of grade ≤1
• Adherence to treatment with Caphosol was high:
• Patients rinsed at least once on 96% of days and 4 or more times on 76% of days
• The majority of head and neck cancer patients and physicians were satisfied with Caphosol treatment:
• 79% of patients and 78% of physicians were satisfied with treatment

Conclusion

The registry data provide further evidence to support the use of Caphosol to treat oral mucositis in patients undergoing chemotherapy, radiation or combined chemoradiation. These data suggest that Caphosol is associated with a low occurrence and severity of oral mucositis. Adherence to treatment was high and both patients and physicians reported high levels of satisfaction

There have been a number of subsequent smaller open label evaluations of Caphosol which have all supported the positive results demonstrated in the Papas data. A simple summary table of these is shown below:

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