Lambrecht, M., Mercier, C., Geussens, Y., & Nuyts, S. (2013). The effect of a supersaturated calcium phosphate mouth rinse on the development of oral mucositis in head and neck cancer patients treated with (chemo)radiation: A single-center, randomized, prospective study of a calcium phosphate mouth rinse + standard of care versus standard of care. Supportive Care in Cancer, 21, 2663–2670.

To investigate whether the addition of a neutral, supersaturated, calcium phosphate (CP) mouth rinse benefits the severity and duration of acute mucositis in patients with head and neck cancer treated with (chemo)radiation

Patients in group A were instructed to use caphosol mouth rinse twice daily with 15 ml solution for one minute plus standard care. Patients in group B were instructed to use standard care consisting of gargling with 15 ml of “magic mouth wash” (hydrocortisone, lidocaine, nystatin, propylene glycol, sodium carboxymethylcellulose, aqua admixture) up to six times per day, swallowing one time out of two. Two experienced physicians conducted visual inspection of the oral cavity and visualized oropharyns weekly until two to seven weeks after completion or until mucositis grade 1 or 0.

• N = 58
• MALES: 84.4%, FEMALES: 15.5%
• Patients had all histological subtypes of head and neck cancer.
• Patients were receiving curative radiation (intensity-modulated radiation therapy of 60–72 Gy over six to seven weeks), primary or postoperative oral mucosa or part of oral mucosa in radiation field, concurrent chemotherapy consisting of 100mg/m² cisplatin at weeks one and four, and induction chemotherapy with docetaxel, cisplatin, fluorouracil, or epidermal growth factor receptor monoclonal antibody.
• Patients were excluded from the study if they had received prior head and neck cancer radiation therapy.

• Single site
• Outpatient radiotherapy department at the University Hospital of Leuven, Belgium

PHASE OF CARE: Active antitumor treatment

• Single center
• Prospective randomized controlled (no placebo) study

• The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3 (NCI CTCAE 3.0)
• Oral pain was scored with a visual analog scale.

No significant differences were found in grade, time of onset, or duration of peak mucositis between groups. Fewer patients in the study arm experienced grade 3 or higher mucositis (59% versus 71%). Mean time to development  of mucositis was 28.6 days in the study group versus 28.7 days in the control group (p = .96). Duration of mucositis was 22.7 days in the study group versus 24.6 days in the control group (p = .62). No significant reduction in the need for analgesics was found.

An oral solution of neutral CP mouth rinse does not reduce frequency, duration, or severity of oral mucositis or pain in patients treated with (chemo)radiation for head and neck cancer. No evidence supports its standard use.

• Small sample (< 100)
• Key sample group differences that could influence results
• Other limitations include the heterogeneity of the patient population and treatment sample and no assessment of patient characteristics that could influence mucositis (poor oral health, alteration salivary production, alcohol use, or existing mucosal damage).

Mucosal damage continues to be an important and debilitating side effect that warrants continued research.