After screening procedures confirm participation in the research study, participants will be randomized one of two groups:
Participants in the experimental arm will complete questionnaires and then receive a single dose of CBD prior to diagnostic CT scan.
Cannabidiol: Oral, per protocol dosage, single dose
Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

After the screening procedures confirm participation in the research study, participants will be randomized one of two groups:
Participants in the placebo arm will complete questionnaire and then receive a single dose of placebo prior to diagnostic CT scan.
Placebo: Oral, per protocol dosage, single dose
Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

Advanced Breast Cancer

Anxiety

Cannabidiol

Placebo

Dana Farber Cancer Institute

RCT of CBD for Anxiety in Advanced Breast Cancer

Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer

The change in anxiety score will be calculated for each patient and a Wilcoxon rank sum test will be used to assess whether the change score is different among patients randomized to CBD as compared to placebo.

Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) and a qualitative assessment, patient-reported side effects and acceptability of taking oral CBD (versus placebo) for managing anticipatory anxiety.

Measured by VAMS subscales-The Visual Analog Mood Scale (VAMS) a validated in-the-moment measure of eight specific mood states: Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense. Subjects are asked to mark their mood along this continuum. The measure is scored using a metric ruler

Measured by the European Organisation for Research and Treatment of Cancer core quality of life questionnaire-nausea subscale.
The EORTC-QLQc30 is a widely used and validated measure of symptom burden.

Pain levels (as measured by the PEG) 3 +/- 1 hour after study agent administration in patients with advanced cancer.

pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Ilana Braun, MD

Principal Investigator

Dana-Farber Cancer Institute

Hans and Mavis Lopater Foundation

patients with invasive breast cancer who received 640 mg oil fish pearls 3 times a day

patient with invasive breast cancer who received corn oil pearls as placebo 3 times a day

Breast Cancer

Active Comparator:640 mg oral oil fish pearls( 54% DHA, 10% EPA) 3 times a day

breast neoplasms/kukurūza

RCT of CBD for Anxiety in Advanced Breast Cancer

Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer

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