The Use of Cannabidiol in Cancer Patients

Cancer Clinical Trial

— CANPADIOL  

Official title:

Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407298
• Other study ID #: 2022Ao001
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Non applicable
Non Applicable

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CBD consummation among patients receiving anticancer treatment		Day 0
Secondary	Knowledge assessment of cancer patients with the CBD medical use in the literacy scope		Day 0