Overview

Effect of Hemp-CBD on Patients With CIPN

Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
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, colorectal, uterine and ovarian cancer patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Main Line Health
Collaborator:
Ananda Hemp, Inc.
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)