Patient Reported Symptom Control With THC or CBD Use

Malignant Solid Neoplasm Clinical Trial

Official title:

Patient Reported Symptom Control With THC or CBD Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875286
• Other study ID #: 2019-0753
• Secondary ID: NCI-2021-0285320
• Status: Recruiting
• Start date: February 3, 2021
• Est. completion date: February 2, 2027

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares patients' attitudes regarding marijuana products for medical use and other treatments for cancer-related pain. This study may help researchers gain better understanding of patient's perception on their use of marijuana products in treating cancer-related pain and other common cancer-related symptoms.

Description:

PRIMARY OBJECTIVE:

I. To determine the patient's reported preference for cancer pain improvement with opioids, opioids with delta-9-tetrahydrocannabinol (THC)-marijuana and/or opioids with cannabidiol (CBD).

SECONDARY OBJECTIVES:

I. To determine the association between perception of cancer-related symptom relief and use of THC-marijuana and/or CBD.

II. To compare patient perception of THC-marijuana and/or CBD versus (vs.) cancer treatments in treatment of cancer.

III. To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD.

IV. To evaluate patient reported concerns while using THC-marijuana and/or CBD. V. To evaluate patient attitude of dosing, forms and use of THC-marijuana and/or CBD.

VI. To evaluate demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD.

VII. To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state.

VIII. To explore the patient reported preference of THC-marijuana and CBD for cancer pain and symptom relief of patients in a Supportive Care Center vs. Integrative Medicine Center at University of Texas (U.T.) MD Anderson.

OUTLINE:

Patients' medical records are reviewed and then complete questionnaires over 27 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (inpatient or outpatient) seen by the Palliative Care and Integrative Medicine teams at The University of Texas MD Anderson Cancer Center (Texas) and the Palliative Care team at Banner MD Anderson Cancer Center (Arizona)

• Patients must be primary residents of Texas or Arizona

• Patients able to speak and read English

• Patients are 18 years old and above

• Patients should have a cancer diagnosis, cancer-associated pain, and taking strong opioids (morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, methadone, fentanyl)

• Patients who have used in the past 3 months or are using alternative botanical pain management while under prescription opioids

Exclusion Criteria:

• Patients who are not able to speak or read English

• Altered mental status as determined by the interviewer based on the ability to understand the nature of the study and consent process

• Patients who have not used medical marijuana and/or CBD products

• Patients who do not have cancer

• Patients who do not have cancer-associated pain

• Patients who are not taking opioids

Related Conditions & MeSH terms

• Cancer Pain
• Cancer-Associated Pain
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Electronic Health Record Review
Medical records reviewed
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who prefer opioids with THC-marijuana and/or opioids with cannabidiol (CBD) to opioids alone for their cancer pain relief	Will be calculated and reported along with a 95% confidence interval.	through study completion, an average of 1 year
Secondary	Perception of cancer-related symptom relief	Will be associated with use of THC-Marijuana and/or CBD. Will be evaluated by generalized linear mixed models to account for the dependency among those patients who have used/are using both.	through study completion, an average of 1 year
Secondary	Patient perception of THC-marijuana and/or CBD	Compared to cancer treatments in treatment of cancer. Will be evaluated by generalized linear mixed models to account for the dependency among those patients who have used/are using both.	through study completion, an average of 1 year
Secondary	To evaluate patient report of adverse effects experienced while using THC-marijuana and/or CBD	Patient reported outcomes will be summarized by frequency and proportion.	through study completion, an average of 1 year
Secondary	To evaluate patient reported concerns while using THC-marijuana and/or CBD	Patient reported outcomes will be summarized by frequency and proportion.	through study completion, an average of 1 year
Secondary	Patient attitude of dosing, forms and use of THC-marijuana and/or CBD	Patient reported outcomes will be summarized by frequency and proportion.	through study completion, an average of 1 year
Secondary	Demographic, physical and psychosocial factors that influence patient perception and attitudes of THC-marijuana and/or CBD	Will be evaluated by Wilcoxon rank sum (Kruskal-Wallis) test or chi-square (Fisher's exact) test, when appropriate. To further evaluate these associations, univariate and multivariable logistic regression models will be fitted. Multiple comparisons will be adjusted where appropriate.	through study completion, an average of 1 year
Secondary	To explore the difference of patient perception of THC-marijuana and CBD in cancer centers in a legalized vs. a non-legalized state.	Differences will be explored.	through study completion, an average of 1 year
Secondary	Patient reported preference of THC-Marijuana and CBD for cancer pain and symptom relief of patients	Will be explored between a Supportive Care Center vs. Integrative Medicine Center at University of Texas (U.T.) MD Anderson. Will be evaluated by Wilcoxon rank sum (Kruskal-Wallis) test or chi-square (Fisher's exact) test, when appropriate. To further evaluate these associations, univariate and multivariable logistic regression models will be fitted. Multiple comparisons will be adjusted where appropriate.	through study completion, an average of 1 year

External Links

•   MD Anderson Cancer Center Website