Topic: National Cancer Research Network, Oral and Gastrointestinal
Conditions
Interventions
Assuming that 20% of the patients of the control group report the successful outcome (30%+ reduction in symptoms on the VAS) and 60% of patients on the active device will do so, the sample size requir
Sponsors
University College London Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. To be at least 18 years old 2. To have received more than 40 Gy of external beam radiotherapy (RT) for cancer in the head and neck region at least 4 months before entry into the study 3. To have grade 1 or 2 of Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema 4. To have a degree of minimum degree of dryness of 50mm (=50mm) on a 100mm Visual Analogue Scale (VAS) scale (0=no dryness; 100=maximum dryness) 5. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax) 6. To have at least one parotid gland; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Exclusion criteria
Exclusion criteria: 1. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V) 2. To have known allergy to materials similar to those used in the investigational product 3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids 4. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes) 5. To use of pilocarpine as systemic therapy 6. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min) 7. To have no parotid glands
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Home diary; Timepoint(s): To record fequency of device application and weekly VAS dry mouth score 2. Quality of Life Measures; Timepoint(s): QoL questionnaires. Month 0, 1, 2, 4, 6, 8, 12 as part of follow up appointments 3. Salivary flow measurement; Timepoint(s): During month 0, 1, 2, 4, 6, 8, 12 of the trial as part of follow-up appointments | — |
Primary
| Measure | Time frame |
|---|---|
| VAS dry mouth score; Timepoint(s): Month 0 and 12 as part of follow-up appointments | — |
Countries
England, United Kingdom
Outcome results
None listed