An evaluative study on the safety and efficacy of standard anti-emetics compared to standard anti-emetics plus natural cannabinoids extract for the treatment of chemotherapy induced nausea and vomiting

INTERVENTION: 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 CONDITION: Cancer Chemotherapy induced nausea and vomiting Emetogenicity PRIMARY OUTCOME: To evaluate the overall efficacy of standard anti‐emetics compared to standard anti‐emetics plus natural cannabinoids extract for the treatment of CINV. Efficacy will be measured by the proportion of patients that achieve a ‘complete response’, where ‘complete response’ is defined as no vomiting and no use of rescue medication SECONDARY OUTCOME: Adequacy of cannabinoid extract blinding. ; Methods and tools used: Questionnaire will be used to ask each participant the following questions 'Do you think you received the placebo comparator of the cannabis extract medication and why do you think this?' Changes in nutrition status. ; Methods and tools used: Patient Generated ‐ Subjective Global Assessment (PG‐SGA) Changes in quality of life caused by nausea and vomiting. ; Methods and tools used: FACT‐G and FACIT‐F questionnaires. Changes in quality of life. ; Methods and tools used: FACT‐G and FACIT‐F questionnaires. Frequency and severity of acute and delayed retching. ; Methods and tools used: Rhodes Inventory of Nausea, Vomiting and Retching (RINV). Frequency and/or severity of acute and/or delayed vomiting. ; Methods and tools used: Rhodes Inventory of Nausea, Vomiting and Retching (RINV). Influence of previously identified factors that affect the generation of chemotherapy induced nausea and vomiting (CINV). ; Methods and tools used: The Functional Living Index‐Emesis‐5 Day Recall (FLIE‐5DR) Patient adherence to the intervention. ; Methods and tools used: Treatment Adherence Questionnaire/Table Prevalence and/or severity of symptoms associated with treatment. ; Methods and tools used: Edmonton Symptom Assessment Scale (ESAS) 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