Short summary

This 2:1 randomized phase III-study intend to investigate the possible benefit of a tasteless and sugar free chewing gum as a salivary stimulant for patients suffering from xerostomia and hyposalivation after treatment with curative intended radiotherapy for head and neck cancer. Patients in the experimental arm will receive treatment with tasteless and sugar free chewing gum during a one month period of time. In the control arm, patients will receive best supportive oral care. 

Rationale

When treating head and neck cancer, radiation-induced xerostomia and hyposalivation are common late side-effects after curative intended oncological treatment. As a result, patients may experience decreased nutritional intake, unintentional weight loss, altered sense of taste, oral discomfort, increased risk of caries, and compromised quality of life. The severity of xerostomia and hyposalivation are often dose dependent as treatment with radiotherapy causes damage to the salivary glands, changes the viscosity of saliva, and causes great oral discomfort. 

Several years after having finalized radiotherapy, a great amount of patients are still troubled by side-effects to their oncological treatment, which has a negative impact on the patients' quality of life. There is a wide range of approaches to symptomatic relief of xerostomia and hyposalivation varying from saliva gel to acupuncture. However, no systematic approach with regular use of saliva stimulants in the form of tasteless and sugar free chewing gum has been conducted on head and neck cancer patients treated with radiotherapy.

In 2014, we conducted a pilot study to investigate the possibility to mechanically stimulate residual saliva function by using a tasteless and sugar free chewing gum.  We found that chewing gum was able to immediately stimulate and increase mean salivary flowrate, however no prolonged effect was observed after 14 days of use. Oral well-being and patient reported outcomes regarding xerostomia improved by the end of the study.

The purpose of this study is to evaluate the possible benefit of a tasteless and sugar free chewing gum as a salivary stimulant for patients treated with curative intended radiotherapy for head and neck cancer. We hypothesize that:

1. Chewing gum can stimulate salivary flow from the residual functional salivary gland and thereby improving the oral well-being of the patient.
2. Regular use of the chewing gum will change the viscosity of saliva and decrease the subjective feeling of xerostomia.
3. The ability to stimulate salivary flow is correlated to the mean dose of radiotherapy delivered to the salivary (parotid, submandibular, and sublingual) glands.
4. Chewing gum prior to eating solid food will aid the eating process 

Description of the cohort

The cohort for this study will be recruited in continuation of a scheduled visit to the Department of Oncology. The cohort includes both men and women and has no upper age limitations.

Patients eligible for this study:

• Diagnosed with an oral or oropharyngeal tumor
• Finalized treatment with radiotherapy (and possibly concomitant chemotherapy)
• Suffer from xerostomia.

Patients can be included within 6 to 24 months after completed treatment. 

Data and biological material

Questionnaire data concerning quality of life, symptom score and patient reported outcomes.

• EORTC-QOL-HN35
• The Groningen Radiation-Induced Xerosomia (GRIX).

Patient and register data regarding treatment modality, tumor stage, and radiotherapy

• Patient demographic
• Radiation plan and dose estimations
• The Danish Head and Neck Cancer Group register (DAHANCA)

Biological material in terms of saliva samples will be collected using sialometry before and after intervention with chewing gum to measure hyposalivation and determines salivary viscosity. No biobank will be established during the project.

• Whole unstimulated salivary flow rate
• Chewing-stimulated salivary flow rate
• Salivary viscosity. 

Collaborating researchers and departments

Department of Oncology, Odense University Hospital

• Associated Professor Jesper Grau Eriksen, PhD
• Professor Carsten Brink, PhD
• Clinical Dietitian Lone Stenfeldt

Fertin Pharma A/S, Vejle

• Clinical Research Manager Birgitte Hyrup Andersen, PhD