None listed
Conditions
Brief summary
This clinical trial aims to compare the safety and efficacy of Cannabinoid Nasal Spray Micelle as an adjunct therapy for the treatment of chemotherapy induced nausea and vomiting in chemotherapy-naive oncology patients. Who is it for? All chemotherapy-naive patients receiving moderate-high emetogenicity chemotherapy aged 18 years or over. Study details: All participants in this study are randomly allocated to one of the two groups. Participants in one group will use a cannabinoid derived nasal spray in addition to standard nausea and vomiting treatment for five chemotherapy days. Participants in the second group will use a nasal placebo spray in addition to standard nausea and vomiting treatment for five chemotherapy days. There is a 50% chance of being assigned to one of the two groups. Participants are expected to have routine blood tests as standard of care provided by the medical oncologists. In addition, participants are expected to complete multiple questionnaires provided by the study investigators. The questionnaires will include 1) One RINV questionnaire per day (one on the day of chemotherapy, and one each of the 4 days post chemotherapy. 2) Two FACT-G/FACIT-F questionnaires per cycle. 3) One FLIE-5DR questionnaire per cycle. 4) Two ESAS questionnaires per cycle. 5) One Adherence Questionnaire for each day the participant receives the study medication. This study aims to see a 'complete response', where 'complete response' is defined as no vomiting and no use of rescue medication.
Interventions
The clinical study will investigate the efficacy and safety of a nasal spray delivered whole plant derived cannabinoid (CBD) extract. The patient will be instructed to initially administer 5 mg of CBD active ingredient, per spray per nostril, prior to commencing chemotherapy providing a total dose of 10 mg. Administration of additional sprays will be a maximum of 6 sprays per nostril over the next 24 hours for a total of 70 mg/day on chemotherapy day and 60 mg/day (6 sprays per nostril) on days
The clinical study will investigate the efficacy and safety of a nasal spray delivered whole plant derived cannabinoid (CBD) extract. The patient will be instructed to initially administer 5 mg of CBD active ingredient, per spray per nostril, prior to commencing chemotherapy providing a total dose of 10 mg. Administration of additional sprays will be a maximum of 6 sprays per nostril over the next 24 hours for a total of 70 mg/day on chemotherapy day and 60 mg/day (6 sprays per nostril) on days 1– 4. Schedule Dose: Day 0 / Chemotherapy Day: Administer 1 nasal spray per nostril prior to commencement of chemotherapy and thereafter 1 nasal spray per nostril every 4 hours [maximum day 0 dose is 70 mg] Schedule Dose: Days 1–4: Administer 1 nasal spray per nostril every 4 hours [maximum day 1–4 dose 60 mg / day] Total Dose to be administered over one chemotherapy cycle is 310 mg of Whole Plant CBD ‘Rich’ Extract Duration: Up to a maximum of 3 chemotherapy cycles Methods and tools used to monitor adherence and capture information for endpoints: 1) Rhodes Inventory of Nausea, Vomiting and Retching (RINV) 2) The Functional Living Index-Emesis-5 Day Recall (FLIE-5DR) 3) Edmonton Symptom Assessment Scale (ESAS) 4) Patient Generated-Subjective Global Assessment (PG-SGA) 5) Functional Assessment of Cancer Therapy-General (FACT-G) and Fatigue (Facit-F) subscale 6) Treatment Adherence Questionnaire/Table
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting all of the following inclusion criteria will be included in the study: 1) Chemotherapy-naive patients receiving moderate-highly emetogenicity chemotherapy. 2) Males and females equal to or greater than 18 years old. 3) Life expectancy >3 months. 4) ECOG performance status equal to or less than 2. 5) Baseline Karnofsky score >60. 6) No concurrent neoplasms or illness that induces nausea independent of chemotherapy. 7) No self-prescribed therapies or complimentary products used for nausea such as ginger. 8) Receiving serotonin 5HT3 or NK1 receptor antagonist medications. 9) Can be reasonably expected to be able to complete the CINV assessment tools. 10) Have provided written informed consent
Exclusion criteria
1) Patients requiring radiotherapy. 2) Previous adverse reaction to or contraindicated to the standard anti-emetics proposed in the study. 3) Pregnant or breast-feeding. 4) Concurrent use of other cannabinoid-containing products. 5) History of adverse reactions to cannabinoids. 6) Patients with malignancies of gastrointestinal tract / gastrointestinal diseases or nausea and vomiting due to reasons other than chemotherapy. 7) Thrombocytopenia or patients undergoing chemotherapy that, according to physician discretion, is likely to cause thrombocytopenia (platelets <50 x 10^9/L). 8) Currently prescribed warfarin or on any other form of anti-coagulant therapy.
Outcome results
None listed