Study ID: F/N-R19-3893L
Coala-T-CBD Study: A Study of the Effect of Hemp-CBD on the Severity and Duration of Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Neurotoxic Chemotherapy for Non-Metastatic Breast, Uterine, Ovarian and Colorectal Cancers
Neuropathy is a dysfunction of one or more peripheral nerves and typically causes tingling, pain, numbness and/or weakness. Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication of many cancer treatments, and therapeutic approaches to relieve CIPN have not been widely effective.
Treatment with cannabidiol (CBD), a naturally occurring compound found in the resinous flower of cannabis, has been shown in human studies to relieve pain (vs. a placebo) from neuropathy related to diabetes, spinal cord injury, multiple sclerosis and other conditions. Researchers seek to determine if CBD can reduce the severity and duration of CIPN among patients who have been diagnosed with non-metastatic cancer of the breast, uterus, ovary or colon.
CBD is an industrial hemp product that is commercially available. The U.S. Farm Bill, signed into law in 2018, changed certain federal regulations relating to the production and marketing of hemp, and the product was removed from the list of controlled substances, thus allowing it to be used in specific dosages in consumer products.
Participants in this trial are randomized into two groups. One group takes placebo pills daily for 12 weeks. The other group takes oral CBD gelcaps daily for 12 weeks.
During the trial, they will be expected to keep a daily log documenting pill consumption and any new symptoms. There will be one additional visit one month after ending treatment.
The primary purpose of this double-blind, randomized, placebo-controlled study is to assess the effect of the cannabidiol (CBD) product Ananda Hemp Spectrum Gelcaps on the severity and duration of chemotherapy-induced neuropathy (CIPN) diagnosed in non-metastatic breast, colorectal, ovarian or uterine cancer patients.
Eligible participants must have a CTCAE sensory score of 2 (sensory alteration or paresthesia, interfering with function but not interfering with activities of daily living) or 3 (sensory loss or paresthesia interfering with activities of daily living), but not above.
Patients taking certain medications may be excluded. Contact the clinical trial coordinator for the complete list of excluded drugs.
The product being tested is a non-psychoactive industrial hemp product with trace-THC (≤ 0.3%) concentration that is currently available commercially as an herbal supplement. The active ingredient is hemp-derived, cannabis sativa extract. Each gelcap contains 15mg CBD. Each participant takes three gelcaps, three times per day, for a total daily dose of 135mg.
- Must have been diagnosed with one of the following:
- non-metastatic breast cancer and developed CIPN (CTCAE grade 2 or 3) after receiving taxane-based chemotherapy in pre- or post-operative setting
- non-metastatic colorectal cancer with high-risk, stage II or III disease and who developed CIPN (CTCAE grade 2 or 3) after receiving oxaliplatin in the adjuvant setting
- ovarian cancer and developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting
- uterine cancer and developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting
- Must not have a history of genetic/familial neuropathy
- Must not use recreational or medicinal marijuana products or illicit drugs
- No underlying liver disease
- Must not have uncontrolled mental health disorder
- Must not have uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months
- Other inclusion and exclusion criteria apply