Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ove Andersen
• Collaborators: Glostrup University Hospital, Copenhagen; North Denmark Regional Hospital; Region Hovedstadens Apotek; University Hospital Bispebjerg and Frederiksberg; University of Copenhagen
• Treatments: Nabiximols

Criteria

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 ( journal)

• Patients with significant edema on the days of the trial (journal / visual inspection)

• In active treatment of cancer or have disseminated cancer (journal)

• Known with brain - or kidney tumor (journal)

• Known with angina pectoris or intermittent claudication

• Known with stroke, AMI, or heart failure (NYHA III-IV) within the past 5 years (journal)

• In isolation

• Obs. Covid-19