Patient Reported Symptom Control With THC or CBD Use | NCT04875286

Studies
Patient Reported Symptom Control With THC or CBD Use

NCT04875286

Sponsor

M.D. Anderson Cancer Center

Status

Active, not recruiting

Last Update Posted

Mar 5, 2026Actual

Enrollment

200Actual

Phase

Not provided

Conditions

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

Interventions

Electronic Health Record Review
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-02853	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2019-0753	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2021Actual

Primary Completion Date

Feb 2, 2027Estimated

Completion Date

Feb 2, 2027Estimated

First Submitted Date

Apr 22, 2021

First Submission Date that Met QC Criteria

May 1, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (medical record review, questionnaires))		Patients' medical records are reviewed and then complete questionnaires over 27 minutes.	Other: Electronic Health Record Review Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electronic Health Record Review	Other	Medical records reviewed	Observational (medical record review, questionnaires))

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Patient perception of THC-marijuana and/or CBD

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Kimberson C Tanco	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Gilbert	Arizona	85234	United States
M D Anderson Cancer Center

Label	URL
MD Anderson Cancer Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D000072716	Cancer Pain
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided