The Use of Cannabidiol in Cancer Patients

NCT ID: NCT05407298

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-04-30

Brief Summary

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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

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* 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.

Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CBD users

Non applicable

Intervention Type OTHER

Non Applicable

CBD non-users

Non applicable

Intervention Type OTHER

Non Applicable

Interventions

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Non applicable

Non Applicable

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

Other Identifiers

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2022Ao001

Identifier Type: -

Identifier Source: org_study_id

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