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The Use of Cannabidiol in Cancer Patients (CANPADIOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05407298
Recruitment Status : Completed
First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Other: Non applicable

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 Design
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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation
Actual Study Start Date : November 15, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Groups and Cohorts
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Group/Cohort Intervention/treatment
CBD users Other: Non applicable
Non Applicable
CBD non-users Other: Non applicable
Non Applicable


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of CBD consummation among patients receiving anticancer treatment [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Knowledge assessment of cancer patients with the CBD medical use in the literacy scope [ Time Frame: Day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients (>18yo) who received anticancer treatment during the inclusion period
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407298


Locations
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France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT05407298    
Other Study ID Numbers: 2022Ao001
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Cannabidiol
cancer patient