IMmunotherapy: Prospective Assessment of Cannabis Treatment in Cancer

NCT06206941 | Recruiting

• 1 other identifier: STUDY0007957
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (8)

• Patient Reported Outcomes Measurement Information System: Pain interference

  Pain interference with daily life and enjoyment on a 5 item scale of not at all to very much. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Patient Reported Outcomes Measurement Information System: Sleep

  PROMISE sleep disturbance on a 5 item scale of not at all to very much. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Patient Reported Outcomes Measurement Information System:Anxiety

  Anxiety on a 5 item scale of never to always. Higher score indicates worse outcome. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Adverse reaction of Cannabis

  Adverse reaction to Cannabis Scale of present side effects and 5 item scale of how distressing the symptoms were experienced. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Cannabis Use Disorder Identification Test

  Cannabis Use Disorder Identification Test (CUDIT), the usage of cannabis and 5 item scale of never to daily or almost daily. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Patient Reported Outcomes Measurement Information System: Depression

  Emotional Distress-Depression on a 5 item scale of never to always, level of sexual activity, emotional well-being, functional well-being and additional concerns on a 5 item scale not at all to very much. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

• Patient Reported Outcomes Measurement Information System: Cognitive Function

  Cognitive Function-Abilities on a 5 item scal not at all to very much. Higher score indicates better outcome.

  0,1,2,4,6,9 and 12 months

• Patient Reported Outcomes Measurement Information System: Fatigue

  Level of fatigue on a 5 item scale of never to always. Higher score indicates worse outcome.

  0,1,2,4,6,9 and 12 months

Secondary Outcomes (2)

• Quality of Life with cancer

  0,1,2,4,6,9 and 12 months

• Area Deprivation Index

  0, 2, 6, and 12

Other Outcomes (1)

• Immunological markers

  0, 2, 6 and 12 month

Study Arms (2)

Cannabis User

Cancer patients being treated with immunotherapy and using cannabis

Cannabis non-user

Cancer patients being treated with immunotherapy and not using cannabis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients that are treated or plan to be treated with immunotherapy.

You may qualify if:

• adult age of 21 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

You may not qualify if:

• use synthetic cannabis or only use Cannabidiol (CBD)
• non users but used in the past 3 months
• prior immunotherapy, 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Thomas Jefferson University: collaborator
• Oregon Health and Science University: collaborator

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Rebecca L Ashare, PhD

CONTACT

716-829-6273; rlashare@buffalo.edu

Colleen K Kilanowski, MS

CONTACT

716-829-5977; ckk@buffalo.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 16, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)