CompletedPhase 1ACTRN12618001205224

A study investigating safety, dosing and effectiveness of medicinal cannabis for symptom relief for patients with advanced cancer

An open label pilot study investigating safety, dosing and efficacy of cannabinoid medications for symptom relief in advanced cancer patients undergoing palliative care.

Sponsor

The University Of Queensland

Enrollment

15 participants

Start Date

Oct 15, 2018

Study Type

Interventional

Conditions

Psychological effects Pain Cancer Fatigue Shortness of Breath Nausea

Summary

Recently there has been a growing interest in the use of cannabis to try and relieve symptoms of pain, nausea, shortness of breath, anxiety, and depression, in patients with advanced cancer. The purpose of this study is to determine an appropriate dosing regimen, safety and efficacy for THC and CBD (both components of cannabis) for symptom relief in patients with advanced cancer. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with advanced cancer. Study details Participants will be allocated into 1 of 2 treatment arms. Group 1 will be receiving CBD (cannabidoil) and Group 2 will be receiving THC (Delta-9-Tetrahydrocannabinol). Determination of the treatment given to the participant will be based on the participant, the treating doctor, and the supply of the medication. Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. Participants will be required to have a blood test and if any females are of child bearing potential a urine test to determine eligibility. It is hoped that this research will be effective in determining a safe and effective dose for symptom relief in patients with advanced cancer.

Eligibility

Sex: Both males and femalesMin Age: 25 Yearss

Inclusion Criteria11

Patients with advanced histologically proven cancer (metastatic or locally advanced solid tumours or advanced haematological malignancies) who have been referred or known to the palliative care team who:
have an ESAS TSDS >10
at lease one individual ESAS score >3
AKPS score >30
aged >25yrs. English speaking (or interpreted available), give fully informed consent
have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12
weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and
for at least 12 weeks following the last dose of the study drug
able to tolerate oral medication and comply with trial requirements
agree to use no other cannabis based product
understand it is illegal to drive a motor vehicle

Exclusion Criteria13

Patients with:
a history of hypersensitivity to any cannabinoid product
unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive cardiac failure)
severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal range. Asparate aminotransferase (AST), and Alanine
aminotransferase (ALT) >3.0 time the upper limit. Subjects with liver metastasis may have an AST and ALT >5.0 time the upper limit
severe renal impairment (eGFR <20mls/min/1.73m2)
history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia, first degree relative with schizophrenia
and/or suicidal ideation)
cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30; known substance use disorder (ASSIST - Alcohol, Smoking and
Substance Involvement Screening Test) examination score <27+; historyof drug diversion may be a risk for them or their family/carers
females who are pregnant or lactating
participation in a trial of a new clinical entity with the last 28 days
treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) within the last 21 days or radioation within the last 7 days

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Interventions

This study is a prospective, two-arm, open label trial of escalating doses of Cannabidiol (CBD) and Delta-9-Tetrahydrocannabinol (THC). The choice of the study drug will be at the discretion of the patient, doctor and dependent on supply. Each patient will follow a dose titration schedule for 14 days and a follow on stable dose for a further 14 days. Concentration of medication: Arm 1: CBD (Cannabidiol 100mg/ml) oral oily liquid Arm 2: THC (Delta-9-Tetrahydrocannabinol 10mg/ml) oral oily liquid Dosing schedule Dose titration (days 0 – 14) will be confirmed by the treating doctor with doses starting at: Arm 1 Days 0 & 1 – 1 dose/day = total daily dose 50mg (0.5ml) Day 2 & 3 – 1 dose/day = total daily dose 100mg (1ml) Day 4 & 5 – 2 dose/day = total daily dose 200mg (2ml) Day 6 & 7 – 3 doses/day = total daily dose 300mg (3ml) Day 8 & 9 – 3 doses/day = total daily dose 400mg (4ml) Day 10 & 11 – 3 doses/day = total daily dose 500mg (5ml) Day 12 & 13 – 3 doses/day = total daily dose 600mg (6ml) Day 14 – 28 – Continue on final dose reached Arm 2 Days 0 & 1 – 1 dose/day = total daily dose 2.5mg (0.25ml) Day 2 & 3 – 1 dose/day = total daily dose 5mg (0.5ml) Day 4 & 5 – 2 dose/day = total daily dose 10mg (1ml) Day 6 & 7 – 3 doses/day = total daily dose 15mg (1.5ml) Day 8 & 9 – 3 doses/day = total daily dose 20mg (2ml) Day 10 & 11 – 3 doses/day = total daily dose 25mg (2.5ml) Day 12 & 13 – 3 doses/day = total daily dose 30mg (3ml) Day 14 – 28 – Continue on final dose reached Each patient will be advised to increase their dose according to the dosing schedule until they are satisfied with their symptom improvement and there are no unacceptable side effects (according to CTCAE graded >4). The patient then will be given the option of remaining on the cannabinoid preparation for continuing assessment of efficacy and adverse events for a total of 28days. Patients will have the choice of lowering their dose according to symptom improvement. Dose titration downwards will be in consultation with the doctor.