New clinical trial offers potential treatment for pain and tingling related to chemotherapy treatment
Today’s innovative cancer therapies are saving more lives, but these extra benefits can cause significant side effects. One of the difficult treatment side effects that many patients experience is chemotherapy-induced peripheral neuropathy, or CIPN.
Peripheral neuropathy refers to nerve damage, most often due to an injury, infection or chronic health issue like diabetes. But CIPN is a specific kind of peripheral neuropathy that occurs as a result of chemotherapy treatment. Patients with CIPN commonly report numbness, tingling, pain or loss of sensation in their hands, legs and feet, which can make the activities of daily life difficult.
"CIPN can make it hard to button your shirt, open a jar of food, or even pick up a pen when your fingers are numb; and it’s painful to wear shoes when your have “pins and needles” sensations in your feet,” explains Marisa Weiss, MD, founder of Breastcancer.org and director of breast radiation oncology at Lankenau Medical Center, part of Main Line Health. “Not only does your quality of life suffer, but severe CIPN may limit your ability to complete chemotherapy resulting in a lower survival,” says Dr. Weiss.
For some patients, CIPN can be persist months and even years after treatment is complete.
"Some of our most effective chemotherapy drugs, given for multiple rounds, are more likely to cause CIPN, like paclitaxel (taxol), docetaxel (taxotere), oxaliplatin and carboplatin, which are commonly used to treat patients with breast, ovarian, endometrial and colon cancers. ”Doctors work hard to minimize all side effects of chemotherapy as much as possible, but CIPN is both difficult to prevent and treat,” explains Dr. Weiss.
What are the treatment options for CIPN?
The Coala-T-CBD study utilizes a hemp-derived CBD product that is commercially available for human consumption. It is not marijuana and is not intoxicating.
“Our hope is that we can harness the power of this natural substance to provide some relief to patients who are suffering from CIPN. This is an opportunity for us to explore a solution that can ease that burden by improving daily quality of life,” says Dr. Weiss.
Participants in the Coala-T-CBD study will be divided into two groups. One group will receive CBD gelcaps to be taken three times per day for 12 weeks. The other group will receive placebo gelcaps (gelcaps without CBD) to be taken once a day for 12 weeks. Following this 12-week period, trial participants will receive three additional months of follow-up care.
“This will allow us to determine if the group of patients who are receiving CBD gelcaps experience a significant improvement in their neuropathy symptoms,” explains Dr. Weiss.
The Coala-T-CBD study is currently enrolling participants. To be eligible, patients must have:
- A diagnosis of non-metastatic cancer of the breast, uterus or colon/rectum or any stage of ovarian cancer
- Completed their chemotherapy
- Symptoms of CIPN (numbness, pain, tingling, loss of sensation in limbs)
To view a full list of eligibility and participation criteria, visit the LIMR website. If you’re not a candidate for this study, talk to your doctor about your other options for managing the effects of CIPN. Nerve pain medications may be able to help you manage your symptoms, and your doctor may also be able to offer some advice into lifestyle changes, like using a cane and installing handrails for stability or wearing gloves to avoid burning yourself when cooking or using hot water and soft loose-fitting shoes to reduce foot discomfort.
To learn more about the Coala-T-CBD Study, contact the clinical trial coordinator, Sam Meske, MS, at 484.476.3502 or [email protected]. You can also take a look at other clinical trials currently underway at LIMR for patients with cancer.