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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

Tracking Information
First Submitted Date June 2, 2022
First Posted Date June 7, 2022
Last Update Posted Date June 7, 2022
Actual Study Start Date November 15, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2022)		 Prevalence of CBD consummation among patients receiving anticancer treatment [ Time Frame: Day 0 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 2, 2022)		 Knowledge assessment of cancer patients with the CBD medical use in the literacy scope [ Time Frame: Day 0 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All the patients (>18yo) who received anticancer treatment during the inclusion period
Condition Cancer
Intervention Other: Non applicable
Non Applicable
Study Groups/Cohorts
  • CBD users
    Intervention: Other: Non applicable
  • CBD non-users
    Intervention: Other: Non applicable
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2022)		 350
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2022
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05407298
Other Study ID Numbers 2022Ao001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party CHU de Reims
Original Responsible Party Same as current
Current Study Sponsor CHU de Reims
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date June 2022