Cannabis Gummy for Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cannabis gummy can improve sleep and quality of life for people with cancer. Many cancer patients struggle with sleep issues, and this trial tests if the gummy outperforms usual care. Participants will either take the gummy or continue with their normal care, and researchers will compare the results. People with active cancer who have trouble sleeping might be a good fit for this trial.

As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have generally shown that cannabis is well-tolerated for various conditions, including pain and sleep problems. Many people use cannabis to aid sleep, and while the exact mechanism remains unclear, some research suggests it can improve sleep for certain individuals.

Cannabis contains THC, a substance that can temporarily alter mood and perception. These effects are usually mild but can make some people feel "high." Most users report few side effects, though some might experience dizziness, dry mouth, or changes in appetite. These side effects are typically not serious.

As this trial is in its early stages, it focuses on assessing safety and determining the right dosage, so the safety of the treatment remains under study. However, cannabis is already approved for some medical conditions, indicating it is reasonably safe when used correctly. Always consult a healthcare provider about any concerns before joining a trial.

Why do researchers think this study treatment might be promising?

Most treatments for cancer focus on directly attacking cancer cells through chemotherapy, radiation, or surgery. However, the cannabis gummy works differently by potentially helping to manage symptoms and improve quality of life through a natural, plant-based approach. This gummy contains active compounds from cannabis, like CBD and THC, which are thought to help with pain relief and nausea, common side effects of cancer treatments. Researchers are excited because these gummies offer a new, possibly gentler way to support cancer patients alongside traditional therapies.

What evidence suggests that this treatment might be an effective treatment for cancer-related sleep disturbance?

Research has shown that cannabis edibles, such as gummies, can improve sleep for cancer patients. Participants in earlier studies reported better sleep. While cannabis does not cure cancer, it may alleviate side effects of cancer treatment, such as pain and sleep disturbances. Cannabis extracts appear more effective than delta-9-THC alone, suggesting that the combination of ingredients in gummies might be beneficial. In this trial, one group of participants will receive a nightly dose of a cannabis-based gummy to assess its impact on sleep. Although further research is necessary, early results are promising for using cannabis gummies to aid cancer patients with sleep issues.12345

Who Is on the Research Team?

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Theodore Brasky, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with cancer who are having trouble sleeping. Participants should be able to take a cannabis gummy and complete study assessments. People may not qualify if they have certain health conditions or other reasons that would make participation unsafe, as determined by the researchers.

Inclusion Criteria

AST and ALT < 3X institutional upper limit of normal within past 3 months or predating current cancer regimen
Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m² using Cockcroft-Gault within past 3 months or predating current cancer regimen
English speaking with ability to understand and willingness to sign informed consent
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Exclusion Criteria

Known or suspected history or family history of schizophrenia, bipolar disorder, or other psychotic illness
History of hypersensitivity to cannabis, THC, or CBD
Allergy to any ingredient in edible doses
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nightly dose of a cannabis-based gummy or usual care for 30 days

4 weeks
Blood sample collection on study

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabis Gummy

Trial Overview

The study tests whether taking a cannabis gummy helps improve sleep and quality of life in people with cancer compared to usual care. Sleep patterns and well-being will be measured using devices, questionnaires, and other assessments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (cannabis gummy)Experimental Treatment5 Interventions
Group II: Arm II (usual care)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Theodore Brasky PhD

Lead Sponsor

Citations

Cannabis Gummy for the Improvement of Sleep and ...

This clinical trial tests how well a cannabis gummy works in improving sleep and quality of life in patients with cancer.

What CBD Gummies and Cancer Support Means in Practice

Can CBD gummies treat or cure cancer? No. No credible evidence from peer-reviewed sources or institutions like the NCI supports CBD gummies as a cancer ...

Cannabis, Cannabinoids and Cannabis-Based Medicines in ...

The cannabis extracts were more effective than delta-9-THC alone. They found that cannabis extracts could differentially effect cancer cells and cancer. ...

Cannabis Edibles Can Ease Pain and Improve Sleep for ...

Cannabis Edibles Can Ease Pain and Improve Sleep for Cancer Patients · Study participants experienced a significant boost in sleep quality, ...

Cannabis and Cannabinoids (PDQ®)

Clinical trial results showed no statistically significant weight gain, although patients reported an improvement in appetite.[10,11] 15 mg and ...