Health TrialsbyHealthPanel

Impact of Daily Oral Cannabis Doses in Patients With Cancer

ConditionsCancerCancers, Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanna Babalonis, PhD

About this trial

This 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed locally advanced or metastatic solid tumors with any types. This applies to either newly diagnosed cancer or preexisting ones on treatment.

Patients with active cancers and currently under any line of treatment (please see notable exceptions in the

Disqualifiers

patients taking checkpoint inhibitors and investigational agents will not be eligible - also exclusionary medications).

Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation).

Age ≥18 years.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral cannabis low THC

    Drug

    4 months daily dosing with oral cannabis low THC

  • Placebo Comparator

    Drug

    4 months of daily dosing with oral placebo

  • Oral cannabis high THC

    Drug

    4 months of daily dosing with oral cannabis with high THC

  • Oral cannabis THC/CBD

    Drug

    4 months of daily dosing with oral cannabis with THC and CBD

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Arm 1: Placebo CannabisPlacebo comparator 1 intervention
Group B: Arm 2: Active Cannabis LowActive comparator 1 intervention
Group C: Arm 3: Active Cannabis HighActive comparator 1 intervention
Group D: Arm 4: Active Cannabis (THC+CBD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent of participants that withdraw from the study or are removed due to adverse events

The percent of patients who elect to withdrawal from the study or removed by physician/investigators due AEs or safety concerns in each group will be measured and compared to the placebo group.

Time frame
5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

Secondary outcomes

1

Change in Heart Rate

Heart rate data from smart watch gathered immediately prior to and for 4 hours post-dose

Time frame
During each daily dose (daily for 4 months of daily dosing)
2

Change in O2 saturation

O2 saturation data from smart watch gathered immediately prior to and for 4 hours post-dose

Time frame
During each daily dose (daily for 4 months of daily dosing)
3

Study withdraw rate

Evaluation of the percent of patients who withdraw from the study or removed by physician/investigators for all reasons

Time frame
5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)
4

Cancer Burden Assessment

Evaluate the effects of cannabis on cancer burden total score Total score will be calculated on a scale of 0-184.

Time frame
5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanna Babalonis, PhD

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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