Radiotherapy Induced Xerostomia (RIX). Cancer
Conditions
Interventions
Current interventions as of 22/01/2016:
1. Visco-ease (19.6 mg/mL LMS-611),1 spray under the tongue twice daily to PRN
2. Placebo (physiological saline), 1 spray under
Sponsors
NHS Greater Glasgow & Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided written informed consent 2. Male or female =18 years of age 3. Patients prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of dose of radiation as judged by the CI or PI during the radiotherapy planning process
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/01/2016: 1. Subject is pregnant or breast feeding 2. Subjects with known allergies to egg, soya, or lanolin (sheep’s wool grease) based products 3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure 4. Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent 5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI) 6. Subjects who are unable to complete the questionnaire or diary 7. Subjects who are judged inappropriate for inclusion in the study by the CI or PI 8. Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion Previous exclusion criteria: 1. Subject is pregnant or breast feeding 2. Subjects with known allergies to egg and soya based products 3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjogrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure 4. Subjects who have participated in an investigational study within 30 days prior to signing consent 5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (e.g., metabolic conditions, renal, cardiac or hepatic conditions) 6. Patients who are unable to complete the questionnaire or diary 7. Patients who are judged inappropriate for inclusion in the study by the CI or PI 8. Patients who have had surgery as primary treatment for head and neck cancer (other than neck dissection alone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 22/01/2016: The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment Time points for GRIX primary outcome measure: 1. Visit 1 (Baseline): Start of treatment (day 1) 2. Visit 7: End of treatment (day 40 +/- 3 days) Previous primary outcome measures: Disease specific oral QoL identified from the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire completed at clinic. Baseline characteristics will be summarised for all randomised participants. Efficacy endpoints before, after and as the change during each treatment period will be summarised by treatment group. Time points for GRIX primary outcome measure: 1. Baseline, start of treatment 1 (Day 14) 2. End of treatment 1 (day 18) 3. Start of treatment 2 (day 21) 4. End of treatment 2 (day 25) 5. Start of treatment 3 (day 28) 6. End of treatment 3 (day 32) 7. Start of treatment 4 (day 35) 8. End of treatment 4 (day 39) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/01/2016: 1. Occurrence of any at least possibly device related SAEs throughout the treatment period 2. Number of at least possibly device related SAEs throughout the treatment period 3. Additional safety outcomes including adverse events, withdrawal, vital signs and concomitant medication use 4. Number of treatment administrations as recorded in the patient diary 5. Domiciliary GRIX scores 6. Follow-up GRIX scores taken two weeks after completion of treatment Secondary outcomes will be compared between Visco-ease and the placebo treatment Secondary outcome measure time points: 1. SAEs occurring from Visit 1 (start of treatment) until Visit 8 (follow-up contact) will be recorded each week from Visit 2 onwards, and during follow-up where required 2. SAEs will be recorded throughout the treatment period as per (1.) 3. AEs, Vital Signs and Concomitant Medication will be recorded at each visit from start of treatment to final visit (end of study/premature discontinuation visit) and during follow-up where required 4. Daily diary records including number and timing of treatment administrations will be completed at home by the patient each day, from Visit 1 – Visit 7 5. Daily record cards including GRIX questionnaires will be completed at home by the patient each day, from Visit 1 – Visit 7 6. GRIX questionnaire will be completed by the investigator via telephone call with the patient at Visit 8 (14 +/- 5 days after Visit 7) Previous secondary outcome measures: Ongoing post market surveillance of Adverse Events (AE) 1. Domiciliary (at home) Symptom scores identified from the GRIX questionnaire 2. Global symptom scores 3. Diary rec | — |
Countries
United Kingdom
Contacts
Public Contact- -
Outcome results
None listed