Caphosol is clinically proven to reduce the impact of oral
mucositis15
This randomized 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 hospitalization16
- Less morphine use15
Reduction of painful oral mucositis by supersaturated calcium
phosphate rinse in head and neck cancer patients receiving
chemotherapy and radiation33
Overview
This open-label observational study provides information from a
registry database of cancer patients receiving chemotherapy or
radiation 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 mcuositis 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 many subsequent evaluations of Caphosol which
have all reinforced the positive results shown in the Papas data. A
simple summary table of these is shown below:
| Study |
Study design |
Patient |
Number of patients |
Main findings |
| Papas et al. 2003 |
Double-blind randomized controlled trial |
Undergoing chemotherapy and TBI |
95 |
Caphosol® improved incidence/ severity of oral mucositis and
significantly reduced pain/ morphine requirements vs. control |
| COMFORT registry 2008 |
Open-label observational |
Undergoing chemotherapy and/or radiation |
218 |
95% of chemotherapy patients developed oral mucositis Grade
0/1
2% of chemotherapy patients developed oral mucositis Grade
3/4
|
| Haas 2008 (head and neck cancer patients from COMFORT) |
Open-label observational |
Receiving chemotherapy and/or radiation |
61 |
Low incidence and severity of oral mucositis
High rates of patient and provider satisfaction
High rate of compliance
|
| Miyamoto 2009 |
Retrospective match controlled |
Receiving IMRT for head and neck cancer |
42 |
Caphosol® reduced incidence and severity of oral mucositis vs.
controls |
| Rzepecki 2009 |
Single centre historical control |
Undergoing chemotherapy prior to hematopoietic stem cell
transplant |
44 |
Caphosol® was not associated with the development of severe
(Grade 3/4) oral mucositis |
| Mourao, 2009 |
Single center match controlled |
HSCT patients undergoing autologous transplant & BEAM (mf
) |
10 |
Caphosol® patients had a decrease in all Grades of OM, the
number of days of OM, the severity of pain and level of morphine
required versus the control group |
| Cannas 2009 |
Single center prospective observational study |
Patients receiving myeloablative conditioning regimen |
6 |
Caphosol® reduced incidence and severity of OM (5/6
had no OM).
Since completion of the assessment OM Grade 3-4 has returned in
patients taking conditioning regimen without
Caphosol®.
|
| Feyer, 2009 |
Single center assessment |
Head and Neck patients receiving radiation and/ or
chemotherapy |
11 |
Occurrence of OM retarded and severity reduced. Patients
reported Caphosol® relieved symptoms, reduced mucous formation and
produced mucous of 'freshness'. |
| Markiewicz, 2010 |
Single center assessment |
Patients treated with allo- HSCT split into two equal
groups |
40 |
The Caphosol® recipients were associated with
decreased oral toxicity, shorter duration of and lower pain due to
oral mucositis.
Caphosol® is effective in treating OM and improves patients
quality of life.
|
| Nguyen, 2010 |
Single center retrospective audit |
Patients receiving autologus transplant with high dose
Melphalan |
45 |
Reduction in level of mucositis in Caphosol® group.
30% of patients in Caphosol® group had no mucositis
Caphosol® group had a reduction in the need for opiates.
|
Caphosol is available in the USA and over 40 countries around
the world.