Clinical Experience

Study 1:
A prospective, randomized study for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation

Papas A et al. Bone Marrow Transplant 2003;31:705–712

Overview
This prospective, randomised, double-blind clinical trial demonstrates that Caphosol®, used in conjunction with fluoride treatments, is a significant adjunct in the management of oral mucositis associated with high-dose chemotherapy and radiation therapy.

Methods
The duration and severity of oral mucositis and requirements of opioid medications were prospectively evaluated in 95 patients undergoing haematopoietic stem cell transplantation (HSCT). The treatment arm received 4 topical fluoride treatments plus Caphosol®, while the control arm received topical placebo treatments and a fluoride rinse (0.01% NaF aqueous solution). Patients were instructed to rinse 4 times per day at the start of cancer treatment and up to 10 times per day if they developed severe oral mucositis.

Result
Significant reductions in days of oral mucositis (p=0.00096), duration of pain (p<0.001), days of morphine (p=0.0003), and dose of morphine (p=0.0001) were observed for patients receiving Caphosol® versus fluoride rinse.


clinical graph

Conclusions
This study demonstrates that Caphosol® is a significant adjunct in the management of oral mucositis associated with high-dose chemotherapy and radiation therapy. Caphosol®, when used in combination with fluoride treatment, is superior to fluoride rinse alone in reducing the frequency, intensity and duration of oral mucositis in patients undergoing HSCT.

Study 2:
Reduction of painful oral mucositis by supersaturated calcium phosphate oral rinse in head and neck cancer patients receiving chemotherapy and radiation

Haas M et al. 50th ASTRO congress 2008;
abstract 2530


Overview

This open-label observational registry is a database of cancer patients receiving chemotherapy or radiotherapy treated with Caphosol®. The registry analyzed the effects of Caphosol® in these patients along with the frequency of patient dosing, adherence to Caphosol® treatment and patient and physician global satisfaction assessment


Methods

The effects of Caphosol® on oral mucositis in head and neck cancer patients was 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.


Result

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

Daily adherence with Caphosol® was encouraging:

The majority of head and neck cancer patients and physicians were satisfied with Caphosol® treatment:

graph

Conclusions
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® has a significant impact on the occurrence and severity of oral mucositis. Adherence was high and both patients and physicians reported high levels of satisfaction.

Note: All the references are available on request to EUSA Pharma

This website contains information about Oral Mucositis and the use of Caphosol for the prevention and treatment of Oral Mucositis
Caphosol is a class I medical device, marked CE

©EUSA Pharma (Europe) Ltd. May 2009. All rights reserved. www.eusapharma.com
Registered in England 4555273 Registered Office The Magdalen Centre, Oxford Science Park, Oxford OX4 4GA Vat Registration No: 896 1192 88

www.caphosol.eu