Status:
UNKNOWN
Effect of Hemp-CBD on Patients With CIPN
Lead Sponsor:
Main Line Health
Collaborating Sponsors:
Ananda Hemp, Inc.
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Colorectal Cancer Stage II
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
CIPN is a common complication of many effective cytotoxic agents that can negatively impact patients' treatment course and quality of life. The incidence of CIPN in cancer patients receiving multidrug...
Eligibility Criteria
Inclusion
- Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting.
- Non-metastatic Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving oxaliplatin in the adjuvant setting.
- Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting .
- Uterine cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
- Non-metastatic pancreatic cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
Exclusion
- Family history of genetic/familial neuropathy
- Routine use of recreational or medicinal marijuana products (defined as \> 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD)
- Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal
- Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam).
- Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months
- Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months.
- Patients with uncontrolled psychiatric illness (who meet DSM-V criteria) or who are at increased risk for suicidality based on baseline Columbia-Suicide Severity Rating Scale.
- Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04398446
Start Date
May 27 2020
End Date
April 1 2023
Last Update
September 1 2022
Active Locations (1)
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1
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096