The Use of Cannabidiol in Cancer Patients

Completed

• Conditions: Cancer
• Interventions: Other: Non applicable

• Registration Number: NCT05407298
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study Start: 2021-11-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBD users	Non applicable	-
CBD non-users	Non applicable	-

Primary Outcome Measures

Name	Time	Method
Prevalence of CBD consummation among patients receiving anticancer treatment	Day 0

Secondary Outcome Measures

Name	Time	Method
Knowledge assessment of cancer patients with the CBD medical use in the literacy scope	Day 0

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France