None listed
Conditions
Brief summary
The purpose of this study is to test a medication called LBS-020 in addressing dry mouth in patients who have undergone treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have a history of treated head and/or neck cancer, and have been diagnosed with dry mouth (also known as xerostomia). Study details Participants in this study will be randomised by chance into two groups. Both groups will use a mouthwash 5 times per day for 7 days. One group will use the intervention treatment which includes a medication called LBS-020. The other group will use an identical looking mouthwash that does not include the medication. All participants will complete a number of scales about their symptoms. It is hoped this study will demonstrate the intervention treatment can ameliorate many of the symptoms experienced by patients suffering from radiation/chemotherapy-induced chronic xerostomia.
Interventions
The intervention consisits of a treatment period of 7 days (+1 day visit window). Eligible subjects randomised to the treatment arm will self-administer (orally rinse, swish, and gargle for 60 seconds, and expectorate) at home. Subjects will self-administer 8 mL LBS-020 (150ug/ml) orally five times a day every 3h ± 2h, preferably before meals. Subjects will be provided with sufficient product (vials) for self-administering five times a day for 8 days. At end of treatment phase, subjects will ret
The intervention consisits of a treatment period of 7 days (+1 day visit window). Eligible subjects randomised to the treatment arm will self-administer (orally rinse, swish, and gargle for 60 seconds, and expectorate) at home. Subjects will self-administer 8 mL LBS-020 (150ug/ml) orally five times a day every 3h ± 2h, preferably before meals. Subjects will be provided with sufficient product (vials) for self-administering five times a day for 8 days. At end of treatment phase, subjects will return all unused product. Furhter, subjects will be asked to complete a daily diary for monitoring of the treatment phase.
Sponsors
Lubris LLC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of radiation-induced xerostomia 2. History of treated head and neck cancer with no evidence of active cancer 3. At least 6 months from last cancer treatment 4. A score >= 40 on a 100mm VAS assessing the subject’s mouth dryness (anchors: not dry at all; very dry) 5. Age 18 years or older
Exclusion criteria
1. Evidence of an active oral infection 2. History or presence of oral surface disorders not related to dry mouth 3. Use of any oral topical medication other than the study medications for the treatment of oral diseases including artificial saliva during the study period 4. History of any oral surgery within 180 days prior to the screening visit. Oral surgery will not be allowed during the study treatment period and elective oral surgery procedures should not be planned during the duration of the follow-up period. 5. Presence or history of any oral or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trial procedures 6. Known hypersensitivity to one of the components of the study or procedural medications
Outcome results
None listed