Medicinal Cannabis for Anorexia in Advanced Cancer

• Register: ANZCTR
• Last refreshed on: 6 March 2023
• Main ID: ACTRN12616000516482
• Date of registration: 21/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of New South Wales
• Public title: Medicinal Cannabis for Anorexia in Advanced Cancer
• Scientific title: Phase I/II, dose ranging study of the pharmacokinetics dose-response parameters, and feasibility of vaporised botanical cannabis flower bud in advanced cancer
• Date of first enrolment: 06/02/2017
• Target sample size: 30
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12616000516482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Pharmacokinetics / pharmacodynamics;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Australia

Contacts

• Name: Prof Meera Agar

• Name: Prof Meera Agar

Key inclusion & exclusion criteria

Inclusion criteria: 1) Age 18 years or above;
2) Advanced cancer;
3) Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score less than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
4) English-speaking (or have an interpreter available);
5) Performance status (Australia-modified Karnofsky Scale score) of 40 or above;
6) Written informed consent.

Exclusion criteria: 1) Hepatic impairment (Child’s Stage B)
2) Renal impairment (estimated glomerular filtration rate of <10 mL/min)
3) Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26);
4) Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation);
5) Acute delirium or delirium within < 30 days;
6) Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure);
7) Impaired pulmonary function which prohibits use of vaporiser;
8) Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids;
9) Pregnant, breastfeeding or unwillingness to use oral contraceptives;
10) Substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco).
11) Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
12) Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the criteria for therapies allowed at eligibility assessment
13) Participation in a clinical trial of another chemical entity.
14) Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the treating clinician.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Cancer;Anorexia;
Cancer
Anorexia

Intervention(s)

Botanical cannabis flower bud (Bedrobinol, Bedrocan) administered via inhalation by vaporiser, taken 3 times a day, 1 hour before meal times.at study site under supervision of trials staff. Each dose level is administered for either one or two days as indicated below in a specific order which is the same for all participants, namely:

50 mg Placebo leaf, 0 mg Delta-9-tetrahydrocannabinol (THC) (one day)
8 mg Bedrobinol (dose 1) mixed with 42 mg placebo leaf, 1.08 mg THC (one day)
16 mg Bedrobinol (dose 2) mixed with 34 mg placebo leaf, 2.16 mg THC (one day)
32 mg Bedrobinol (dose 3) mixed with 18 mg placebo leaf, 4.32 mg THC (two days)
50 mg Bedrobinol (dose 4), 6.75 mg THC (two days)

Primary Outcome(s)

Numerical rating scale - Appetite[1, 5, 10, 20, 40 and 60 minutes and 4 hours post inhalation of every dose, and 30 minutes prior to subsequent dose]

Plasma concentrations of delta 9-Tetrahydrocannabinol[trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation after morning dose at each dose level]

Secondary Outcome(s)

Feasibility of vaporisation (report of treating trials nurse on completeness of vaporisation, presence of cough during vaporisation)[each dose three times a day from day 1 to day 7 of treatment]

Hunger, Taste and Smell Survey[baseline and study end (day 7)]

Plasma levels of 11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC)[trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation]

Adverse effects will be assessed using participant self-report on 4-point numerical rating scale and NCI common terminology for adverse events V4.03 (adverse events of interest include neurological (confusion, somnolence), psychiatric (personality change, paranoia, anxiety, mood changes, psychosis), cardiovascular (hypertension, tachycardia), systemic (sweating), and gastrointestinal (nausea, vomiting, abdominal pain)[prior to each dose, and at 1, 5, 10, 20, 40 and 60 minutes and 4 hours after each dose administration]

Anxiety and depression symptoms (composite outcome, PHQ-9 and GAD-7)[baseline and day 7]

Plasma levels of 11-nor-9-carboxy-delta 9-tetrahydrocannabinol (THCCOOH)) [trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation]

Plasma levels of cannabidiol metabolite 7-OH-CBD[trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation]

Feasibility (Number of participants continuing on study/day by review of daily case record forms)[daily from day 1 to day 7 of treatment]

Feasibility (Percentage completion of all measures at all time points by review of case record form completion)[daily from day 1 to day 7 of treatment]

Inpatient resource utilisation (composite outcome) by review of case record forms (total duration of admission, additional days of admission due to toxicity)[daily from day 1 to day 7 of study treatment, and day 8 - 14 of follow-up.]

Daily food intake (self - reported using my fitness PAL)[daily (day 1 - 7 of treatment)]

Global Impression of Change[day 8 and day 14]

Plasma levels of Cannabidiol [trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation]

Satiety Labelled Intensity Magnitude (SLIM scale)[5 minutes before each of the three meals on the baseline day (day 1) and on day 7 ]

Quality of Life (functional assessment of anorexia-cachexia subscale)[baseline and study end (day 7)]

Feasibility (number of participants who complete 7 days of study intervention by review of completion case record form)[day 7]

Quality of Life (EORTC-Pal 15)[baseline and study end (day 7)]

Secondary ID(s)

none

Source(s) of Monetary Support

New South Wales Government Ministry of Health

Ethics review

Status: Approved
Approval date: 15/12/2015
Contact:

Hunter New England Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 27/02/2023
• Date Completed: 20/08/2019