Recruiting

Cannabis Treatment

Sponsor:

State University of New York at Buffalo

Code:

NCT06206941

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this research is to assess how patients with cancer being treated with Immune Checkpoint Inhibitors (ICI) manage symptoms related to cancer and/or its treatment. Patients use a variety of ways to manage symptoms including traditional and alternative treatments including cannabis, acupuncture, etc. This research will have an important impact on our knowledge of cancer symptom management, and ultimately improve patient care and safety.

Participants will complete online surveys and 7 days of ecological momentary assessments at 0, 1, 2, 4, 6, 9 and 12 month to compare the cannabis users and non cannabis users symptoms.

Conditions

Cancer

Study ID

NCT06206941

Start date

Jan 2, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult age of 18 years or older
  • cancer diagnosis and planning or using immunotherapy treatment,
  • pain and spend less than 50% in bed or chair
  • fluent in english language

Exclusion Criteria:

  • use synthetic cannabis or only use Cannabidiol (CBD)
  • non users but used in the past 3 months
  • Patients receiving immunosuppressants or organ transplant recipients.
  • Patients within 6 months of Hospice care.
  • Pain that limits movement to more than 50% of their day in bed or chair

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Cannabis User

Cancer patients being treated with immunotherapy and using cannabis

Cannabis non-user

Cancer patients being treated with immunotherapy and not using cannabis

Primary outcome measure

  • Patient Reported Outcomes Measurement Information System: Pain interference [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Patient Reported Outcomes Measurement Information System: Sleep [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Patient Reported Outcomes Measurement Information System:Anxiety [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Adverse reaction of Cannabis [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Cannabis Use Disorder Identification Test [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Patient Reported Outcomes Measurement Information System: Depression [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Patient Reported Outcomes Measurement Information System: Cognitive Function [ Time Frame: 0,1,2,4,6,9 and 12 months ]
  • Patient Reported Outcomes Measurement Information System: Fatigue [ Time Frame: 0,1,2,4,6,9 and 12 months ]

Central Contacts and Locations

Central contacts

Rebecca L Ashare, PhD

716-829-6273rlashare@buffalo.edu

Colleen K Kilanowski, MS

716-829-5977ckk@buffalo.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Brooke Worster, MD

215-955-1888Brooke.Worster@jefferson.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-08-26.