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OncoMatch/Clinical Trials/NCT06601218

Impact of Daily Oral Cannabis Doses in Patients With Cancer

Is NCT06601218 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Oral cannabis low THC and Oral cannabis high THC for cancer.

Phase 1RecruitingShanna Babalonis, PhDNCT06601218Data as of May 2026

Treatment: Oral cannabis low THC · Oral cannabis high THC · Oral cannabis THC/CBDThis study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.

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Extracted eligibility criteria

Prior therapy

Must have received: anti-cancer therapy

Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment

Cannot have received: checkpoint inhibitor

Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4)

Cannot have received: investigational agent

Current use of investigational agents, <3 months after the use of investigational agents

Lab requirements

Blood counts

lab values demonstrating adequate organ and marrow function at baseline (pre-study)

Kidney function

lab values demonstrating adequate organ and marrow function at baseline (pre-study)

Liver function

lab values demonstrating adequate organ and marrow function at baseline (pre-study)

Cardiac function

ECG and cardiac conditions contraindicated for cannabis use

ECG and lab values demonstrating adequate organ and marrow function at baseline (pre-study); Cardiac conditions contraindicated for cannabis use

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Kentucky · Lexington, Kentucky

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