Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorUniversity of Rochester
About this trial
The goal of this observational study is to evaluate the associations between patient-directed medical cannabis use and chemotherapy-induced nausea and vomiting (CINV), as well as other treatment-related symptoms, among patients receiving chemotherapy that is known to cause nausea. The main questions it aims to answer are:
* Is patient-directed medical cannabis use associated with reduced nausea severity during chemotherapy treatment? * Is-patient directed medical cannabis use associated with improved CINV control? * Is patient directed medical cannabis use associated with improved appetite during chemotherapy treatment? * Is patient-medical cannabis use associated with reduced treatment-related side effects, such as fatigue, sleep disturbances, general pain, and peripheral neuropathic pain?
Researchers will compare participants who report using medical cannabis with participants who do not report using medical cannabis to determine whether differences exist in nausea, CINV outcomes, and other treatment-related symptoms.
Participants will be followed over the course of 3 chemotherapy cycles, and asked to complete questionnaires, nausea diaries, and partake in a blood sample collection. Study participation can last from 6 - 12 weeks, depending on their prescribed chemotherapy cycle frequency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of cancer with no previous chemotherapy treatments (aside from current treatment)
Be scheduled to receive treatment with a chemotherapeutic agent that is classified by the National Comprehensive Cancer Network (NCCN) as having a high emetogenic potential (>90% incidence) or moderate emetogenic potential (30-90% incidence).
Must be scheduled for a minimum of 3 additional chemotherapy cycles at the time of enrollment.
Chemotherapy agents may be given intravenously or orally.
Disqualifiers
Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.
Have any allergies to cannabis or contraindication for cannabis.
Have an active or recent (< 6 months) substance use disorder, as determined by medical history.
Have recently quit smoking (< 6 months) or are actively engaged in a smoking-cessation program.
Trial population
The MOSAIC study aims to enroll 50 participants. The study population consists of both males and females, aged 21 years or older, who are initiating first-line moderately or highly emetogenic chemotherapy, as defined by MASCC/NCCN criteria. Participants must be able to understand and communicate in English, and meet the various inclusion and exclusion criteria to be enrolled into this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Medical Cannabis
DrugParticipant-directed medical cannabis use
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cannabis Use Group1 intervention
Group B: Standard Care Group0 interventions
Trial outcomes
Primary outcomes
1
Average and Maximum Nausea Severity as Measured by the Nausea and Vomiting Diary
Average nausea severity will be measured using a participant completed nausea and vomiting diary. Nausea severity is rated on an 11 point numeric scale anchored by "Not at all nauseated" (0) and "Extremely nauseated" (10). Average nausea is calculated as the mean of up to 15 assessment points, including afternoon, evening, and night on Day 1 and morning, afternoon, evening, and night on Days 2 through 4. Higher scores indicate greater nausea severity. Scores will be set to missing if 11 or more of the 15 assessments are missing. Maximum nausea severity will be measured using a participant-completed nausea and vomiting diary. Nausea severity is rated on an 11-point numeric scale anchored by "Not at all nauseated" (0) and "Extremely nauseated" (10). Maximum nausea is defined as the highest nausea rating reported across the same 15 assessment points.
Time frame
Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)2
Number of Emesis Episodes Recorded in the Nausea and Vomiting Diary
Emesis episodes will be recorded daily by participants using the nausea and vomiting diary. The outcome is the total number of vomiting episodes recorded during the assessment period.
Time frame
Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)Secondary outcomes
1
Complete Protection From Chemotherapy Induced Nausea and Vomiting
Complete protection is defined as no emesis, no use of additional rescue therapy, and no significant nausea defined as a nausea score of 2 or less on a 0 to 10 numeric rating scale. The outcome will be reported as the proportion of participants meeting these criteria.
Time frame
Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)2
Complete Control of Chemotherapy Induced Nausea and Vomiting
Complete control is defined as no emesis, no use of additional rescue therapy, and no nausea defined as a nausea score of 0 on a 0 to 10 numeric rating scale.
Time frame
Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)3
Complete Response to Chemotherapy Induced Nausea and Vomiting
Complete response is defined as no emesis and no use of additional rescue therapy. The outcome will be reported as the proportion of participants meeting these criteria.
Time frame
Days 1-4 following chemotherapy administration during up to 3 on-study chemotherapy cycles (Day 1 defined as the day of chemotherapy administration; each chemotherapy cycle is 14-28 days, depending on regimen)4
Change in Appetite as Measured by the University of Rochester Cancer Center (URCC) Symptom Inventory
Appetite will be assessed using the URCC Symptom Inventory. Appetite is measured on an 11 point numeric scale anchored by "Not at all hungry" (0) and "Extremely hungry" (10). Higher scores indicate greater appetite.
Time frame
Baseline (within 7 days before chemotherapy) and Day 4 following chemotherapy during Cycles 1 and 3; post-cycle questionnaires completed on Day 4 or within 48 hours (Day 1 defined as the day of chemotherapy administration; cycles are 14-28 days).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: