CancerCANPADIOLNCT05407298
The Use of Cannabidiol in Cancer Patients
An observational study of Cancer, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Non applicable
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients (>18yo) who received anticancer treatment during the inclusion period
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Non applicable
- Keywords
- Cannabidiol, cancer patient
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Non Applicable
| Study group | Role | What they receive |
|---|---|---|
| CBD users | Not described Receives: Other: Non applicable | |
| CBD non-users | Not described Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CBD consummation among patients receiving anticancer treatment
Measured: Day 0
Secondary outcomes (1)
Knowledge assessment of cancer patients with the CBD medical use in the literacy scope
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Nov 2021
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407298
- Sponsor's protocol ID
- 2022Ao001
- Acronym
- CANPADIOL
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation
- ClinicalTrials.gov ID
- NCT05407298
- Acronym / sponsor ID
- CANPADIOL / 2022Ao001
- Conditions
- Cancer
- Keywords
- Cannabidiol, cancer patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD users | – | Other: Non applicable |
| CBD non-users | – | Other: Non applicable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients (>18yo) who received anticancer treatment during the inclusion period
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableNon Applicable | Other | CBD non-users, CBD users |
Primary outcome
Prevalence of CBD consummation among patients receiving anticancer treatment
Time frame: Day 0
1 secondary outcome
Knowledge assessment of cancer patients with the CBD medical use in the literacy scope
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CBD consummation among patients receiving anticancer treatment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.