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Effect of Hemp-CBD on Patients With CIPN

NCT04398446 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-09-01

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.

Conditions

Interventions

DRUG

Hemp-based CBD

3x Daily dosing for 12 weeks

OTHER

Placebo oral tablet

3x Daily dosing for 12 weeks

Sponsors & Collaborators

  • Ananda Hemp, Inc.

    collaborator UNKNOWN

  • Main Line Health

    lead OTHER

Principal Investigators

  • Marisa Weiss, MD · Main Line Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2022-11-30
Completion
2023-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398446 on ClinicalTrials.gov