Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan) (NCT05503147) | Clinical Trial Compass
UnknownPhase 1
Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)
Denmark17 participantsStarted 2022-03-24
Plain-language summary
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs.
The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥65 years of age
* Admitted to the acute medical department, Hvidovre Hospital
* Can cooperate cognitively and physically (patient reported)
* Low appetite/anorexia of ageing measures by SNAQ score ≤14
* BMI ≤30 (screening)
* Able to read and understand Danish
* Postmenopausal defined as missed periods for at least 12 months before the start of the trial
Exclusion Criteria:
* Regular use of medical cannabis (patient reported)
* Use of medical cannabis within 14 days at baseline (patient reported)
* Recognized or suspected psychotic illness in the subject or the subjects family (medical record and patient report)
* Severe personality disorders (journal)
* Significant psychiatric disorder in addition to mild to moderate depression (medical record)
* Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported)
* Terminal diagnosis (journal)
* Liver transplant (journal)
* Chronic eGFR ≤15 mL / min2 or dialysis treatment (medical record)
* High risk of nephrotoxicity due to existing drug treatment (medical assessment)
* Pacemaker (journal)
* Epilepsy (journal)
* Recurrent seizures (journal)
* Uncontrolled hypertension (journal)
* Food intolerance to the ingredients in the test meals (patient-reported)
* Vegetarian and vegan (patient-reported)
* Unwilling to avoid driving for up to 72 hours after administration of Sativex® (patient-reported)
* Unwilling to avoid alcohol 24 hours up to test days (patient-reported)
* Patients with ascites…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in energy intake (kJ) between Sativex® and placebo
Timeframe: Trial days 1 and 2.
2
Differences in the objective function value of the population-based pharmacokinetic model when implementing renal clearance assessed by measured GFR (mL/min), or GFR estimates based on different endogenous markers, as covariates on gentamicin clearance