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

Strengths of cannabinoids will vary across groups

Chemotherapy-induced Peripheral Neuropathy

Cannabinoids with different concentrations of THC and CBD

Cannabinoids

1051 Riverside Drive

Cannabinoids for Taxane Induced Peripheral Neuropathy

The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy

Diana Martinez

Psychiatrist II

New York State Psychiatric Institute

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

CIPN in Adjuvant Colon Cancer Patients

CIPN in Adjuvant Breast Cancer Patients

Daily dosing of dietary supplement OnLife

OnLife

Praxis für interdisziplinäre Onkologie & Hämatologie

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)

Questionnaire EORTC QLQ-C30 is used to determine patients' health-related quality of life.

Questionnaire EORTC QLQ-CIPN20 is used to elicit patients' experience of symptoms and functional limitations related to CIPN.

Drug treatment of neuropathic pain is observed over the time of the OnLife® application and the month after the end of OnLife® application

Swiss Medical Food AG

iOMEDICO AG

Patient using cannabis during chemotherapy treatment

1- Cancer Patients During Chemotherapy Treatment

2- Use of Cannabis Comparing to Control Without Cannabis Use

cannabis

Oncology Institute, Rambam Health Care Campus

Evaluation Prospectively the Level of Reduction in Cognitive Functions of Cancer Patients Who Are on Active Oncology Treatments and Use Cannabis. The Second Goal is to Identify High-risk Groups for Cognitive Impairment Due to Cannabis Use.

Cannabis-related Cognitive Impairment: Prospective Evaluation of Possible Influences in Cancer Patients During Active Oncology Treatment

Level of cognitive function as measured by the cognitive tests MoCA and DSST questionnaires and Digital Finger Tapping

cannabinoid/brystkræft

RCT of CBD for Anxiety in Advanced Breast Cancer

Cannabinoids for Taxane Induced Peripheral Neuropathy

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

Evaluation Prospectively the Level of Reduction in Cognitive Functions of Cancer Patients Who Are on Active Oncology Treatments and Use Cannabis. The Second Goal is to Identify High-risk Groups for Cognitive Impairment Due to Cannabis Use.

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