None listed
Conditions
Brief summary
The purpose of this study is to determine the use of sublingual ketamine drug to help with relieving pain for patients with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have significant pain associated with advanced cancer, your body weight is more than 40 kg and are willing to comply with the study requirements. Study details Participants in this study will receive three cycles of two treatment drugs in random orders: 1. sublingual ketamine wafer (flat tablet placing under tongue) for 7 days 2. non-active (sham) wafer for 7 days The first 2 days of each period will be considered analytical washout days and hence will not be analysed for efficacy regardless of whether study medication is taken. Participants will be expected to complete a daily and weekly questionnaires and also have interviews with study staff through either video-conferencing or visit to hospital after each 7-day study period. It is hoped that this research will determine if a larger trial can be completed on evaluating the effect of sublingual ketamine drug as pain relief for management of moderate to severe pain in patients with advanced cancer.
Interventions
Participants will be randomised into one of the following sequences to determine the order of sublingual ketamine (A) and placebo wafer (P):
- AP AP AP
- AP AP PA
- AP PA AP
- AP PA PA
- AP AP AP
- PA AP PA
- PA PA AP
- PA PA PA
Each sequence consists of 3 pairs. Each pair consists of a period (7 days) of A and a period of P. First 2 days of each period will be considered washout days in the analysis. This means that the participants will take the study medication as instructed, but when analys
Participants will be randomised into one of the following sequences to determine the order of sublingual ketamine (A) and placebo wafer (P): - AP AP AP - AP AP PA - AP PA AP - AP PA PA - AP AP AP - PA AP PA - PA PA AP - PA PA PA Each sequence consists of 3 pairs. Each pair consists of a period (7 days) of A and a period of P. First 2 days of each period will be considered washout days in the analysis. This means that the participants will take the study medication as instructed, but when analysing the results, these two days will be considered washout days rather than treatment days. For the next 5 of the 7 days during the period, participants will take study medication as per instruction, and the results will be analysed accordingly. The total duration of the study will be six weeks. Participants will be instructed to use the study drug as a first line breakthrough analgesia. The study drug will be either Sublingual ketamine wafer 25 mg or a placebo wafer. They will take one dose of the study drug no more than every 3 hours, with a maximum of 3 doses per day. When they have reached the maximum allowable study medication per day, they will be taking their usual pain medication as prescribed by their treating physician. This may be their usual short acting opioid medication such as oxycodone or morphine. Participants will be required to complete a study diary which includes the information on the study medication and other analgesic agents taken that day, and will also record any potential side effects. There will be weekly follow up after each 7-day period through either videoconferencing or face-to-face review at the outpatient clinic in the hospital. Participant will be asked to present the Webster-Pak to show the study staff the exact amount used or left in the medication pack.
Sponsors
Chris O'brien Lifehouse
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients with diagnosis of advanced cancer 2. Weight >40 kg, and BMI between 18-40 kg•m-2 3. Moderate to severe pain associated with the cancer diagnosis requiring ongoing opioid analgesia at >60 mg of OMEDD (oral morphine equivalent daily dose) 4. Self-reporting sub-optimal pain control with current analgesia 5. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 2. Participants who are receiving ketamine medication through any route of administration as part their treatment regimen. 3. Participants with a history of raised intra-cranial pressure, epilepsy, raised intra-ocular pressure, severe cardiac failure, or uncontrolled hypertension 4. Participants with a history of cognitive impairment which may interfere with their ability to understand the study requirements. 5. Participants with DSM-V diagnosis of psychotic disorders or dissociative disorders which may resemble the adverse effect of the study medication 6. The requirement of analgesia is expected to decrease following recruitment into the study. 7. Participants with life expectancy of less than six weeks
Outcome results
None listed