Clinical trial NCT05407298: The Use of Cannabidiol in Cancer Patients
Official title: Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cannabidiol
cancer patient
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients (\>18yo) who received anticancer treatment during the inclusion period

Brief summary: Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.

Detailed description: * A Prospective observational study
* Conducted in an oncology day-hospital (CHU de Reims)

All data collected were:

* Clinical characteristics,
* Administrative data,
* Medication review,
* Biologic data collection,
* Oncological data,
* Disease data

Statistical analysis:

* Quantitative variables: described as mean ± standard deviation (SD) or median (Interquartile range and minimum and maximum)
* Student test and Fischer exact performed to compare CBD users and non-users.
* Analysis of variance: used to compare scores between different variables
* Univariate logistic and multivariate logistic regressions were performed. Variables with a p-value \< 0.20 (Wald test) in the univariable analyses were considered eligible for the multivariable models.

Eligibility criteria: inclusion criteria: All the patients (\>18yo) who received anticancer treatment

exclusion criteria:

* Patients who received anticancer drug with very short administration time (typically subcutaneous anticancer drugs as 5-azacitidine, bortezomib and some monoclonal antibodies)
* Patients who were not able to speak and understand French as well as who were unable to communicate clearly.

Primary outcomes:
measure: Prevalence of CBD consummation among patients receiving anticancer treatment
timeFrame: Day 0
Secondary outcomes:
measure: Knowledge assessment of cancer patients with the CBD medical use in the literacy scope
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: