Lankenau Medical Center physician studying if CBD can treat neuropathy in cancer patients
The Coala-T-CBD Study is for patients who have been diagnosed with non-metastatic cancer of the breast, ovary or colon, have undergone chemotherapy, and are experiencing CIPN — a sensation of tingling, pain, numbness and/or weakness in the hands or feet. CIPN is a common complication of various types of chemotherapies used to treat many cancers. Current therapeutic approaches to relieve CIPN are only minimally effective.
“Chemotherapy-induced peripheral neuropathy is one of the most common and difficult side effects of the most widely used chemotherapies. It reduces quality of life and the ability of some patients to complete treatment,” said Marisa Weiss, MD, the co-principal investigator for the study. “We want to determine if CBD can help relieve CIPN in people to improve the patient experience and survival in those who’ve undergone chemotherapy.”
Dr. Weiss also serves as the director of breast radiation oncology at Lankenau Medical Center and an adjunct professor of the Lankenau Institute for Medical Research, the research division of Main Line Health. She is a leading figure in the breast cancer community, as founder and chief medical officer of the organization Breastcancer.org.
CBD is a hemp-based product that is commercially available for human consumption. Hemp is not marijuana and is not intoxicating.
Consumers may have noticed many new products on the market touting CBD as an ingredient. 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.
The Coala-T-CBD Study is a randomized, controlled clinical trial studying hemp-based CBD in patients diagnosed with CIPN. Eligible participants in the trial are randomized into two groups. One group takes CBD gelcaps three times per day for 12 weeks. The other group takes placebo gelcaps daily for 12 weeks. Trial participants then undergo follow-up care for six months.
During the trial, they will have in-person visits with the study team at Lankenau Medical Center every two weeks for clinical neuropathy examinations; regularly complete questionnaires; and keep a daily log documenting gelcap consumption and any new symptoms.
Eligible participants must not have a history of genetic/familial neuropathy, a recent heart attack, uncontrolled cardiovascular disease or liver disease. Patients taking certain medications will be excluded; contact the clinical trial coordinator for the complete list of excluded drugs. Also, eligible participants must not use recreational or medicinal marijuana products or illicit drugs and must not have an uncontrolled mental health disorder. Other inclusion and exclusion criteria apply.
To learn more about the Coala-T-CBD Study, contact the clinical trial coordinator, Sam Meske, MS, at 484.476.3502 or [email protected]. This study is being supported by a research grant from Ananda Health, a division of the Australian-based Ecofibre Co., which also is providing the Ananda Hemp CBD study product.
About Lankenau Institute for Medical Research
Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR's mission is to improve human health and well-being. Using its ACAPRENEURIALTM model that integrates academic and entrepreneurial approaches, faculty and staff are devoted to advancing innovative new strategies to address formidable medical challenges including cancer, cardiovascular disease, tissue regeneration, gastrointestinal disorders and autoimmune diseases such as diabetes and arthritis. LIMR's principal investigators conduct basic, preclinical and clinical research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.