This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance amongst cancer patients, often stemming from physical changes from tumor growth and surgery, side effects from supportive care and chemotherapy, and stress associated with the diagnosis. THC with or without CBD may improve insomnia symptoms and sleep quality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
69
Undergo blood sample collection
Given placebo tincture sublingually
Given THC tincture sublingually
Given THC/CBD tincture sublingually
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in Insomnia Sleep Index score
The Insomnia Sleep Index (ISI) is a brief screening tool used to assess insomnia symptoms and sleep patterns over the past week. It consists of 7 questions answered on a scale of 0 (not al all) to 4 (not very much). Total scores range from 0-28 with higher scores indicating greater severity of clinical insomnia.
Time frame: From baseline to week 4
Change in Quality of Life Score
Assessed using the Linear Analog Scale Assessment (LASA) of Quality of Life (QOL) scale, which consists of a single question related to quality of life over the past week. The scale is answered on a scale of 0 (worst it can be) to 10 (best it can be). Total scores range from 0-10 with higher scores indicating greater quality of life.
Time frame: From baseline to 4 weeks
Change in Daytime Sleepiness
As measured by the Patient-Reported Outcomes Measurement Information System Fatigue (PROMIS-Fatigue) Item Bank instrument. The PROMIS-Fatigue questionnaire, a subscale of the PROMIS-29, measures fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). Total scores range from 4-20 with higher scores indicating greater experience of fatigue.
Time frame: From baseline to end of treatment (day 35)
Average amount of deep sleep
As measured by home electroencephalography (EEG). Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.
Time frame: From baseline to week 4
Average amount of light REM sleep
As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.
Time frame: From baseline to week 4
Average time awake
As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.
Time frame: From baseline to week 4
Amount of sleep per day
As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.
Time frame: From baseline to week 4
Change in mood - PHQ-9
The Patient Health Questionnaire 9-item (PHQ-9) scale is a self-report questionnaire used to assess severity of depression over the last 2 weeks. The PHQ-9 consists of nine items rated on a scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with higher scores indicating greater severity of depression symptoms.
Time frame: From baseline to end of treatment (day 35)
Change in mood - GAD-7
The General Anxiety Disorder 7-item (GAD 7) scale is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 with higher scores indicating more severe anxiety symptoms.
Time frame: From baseline to end of treatment (day 35)
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