Chemotherapy-Induced Peripheral Neuropathy (CIPN) causes nerve pain and loss of sensation, often leading to numbness, tingling, burning, or other symptoms in the hands and feet. CIPN frequently results in changes to chemotherapy treatment, pain, fall risk, and negative impacts on quality of life. Sometimes CIPN goes away shortly after chemotherapy and other times it can last for years. There are treatments for these symptoms but there can be delays in getting those treatments and the treatment options are often not maximized.
This study investigates a new way of helping people who have CIPN after they complete chemotherapy or while they are on maintenance medications, by checking on symptoms daily and using a specially trained nurse practitioner to select the right treatment at the time bothersome symptoms are reported. If the symptoms change, the nurse practitioners can quickly adjust medications or try new solutions to improve how the patient feels.
We hope to show that providing care to patients based on daily reported symptoms, which patients can do from home, will reduce CIPN symptoms over a 12-week period, improve quality of life, and reduce disabilities.
Who Can Participate?
If you have developed CIPN from your current or recently completed chemotherapy, you may be eligible to participate in this study. This study is open to patients who:
- Are 18 years old or older.
- Have either completed specific chemotherapy protocols or taking maintenance therapies known to cause CIPN.
- Have developed CIPN within 90 days of completing the chemotherapy protocol or have been on maintenance medications for 90 days or longer.
- Have at least one moderate or severe neuropathic sensory symptom on the day of screening or during the preceding week.
- Have the ability to speak or read sufficient English to be able to communicate with the study nurse practitioners over the phone, utilize our symptom reporting app, website, or automated phone system, all of which are only available in English.
What Will I Be Asked to Do?
- Study staff will look at your medical record to determine if you are eligible and you will have a conversation with someone from the study team where they can answer any questions you may have.
- You will be asked to complete some questionnaires about your CIPN symptoms and how those symptoms are affecting you. You will also undergo a brief physical examination to assess your neuropathy.
- You will be taught how to use the system through which you will report your symptoms every day. This can be done using a telephone, a smartphone application, or a website. You can decide which one you would like to use on any given day.
- You will record your symptoms every day for one week. After that, if you are eligible to continue in the study based on your symptom reporting, you will be randomly assigned to either a group that will receive calls from a nurse practitioner to treat your symptoms, or a group that will not receive calls but can work with their doctors to treat their symptoms.
- You will continue to record your symptoms daily for an additional 12 weeks.
- There will be two additional visits: one around the six-week mark and another around 12 weeks. During these visits, you'll be asked some of the same questions from your initial visit. You may choose to complete these visits either in person or by phone.
- You will be compensated for your participation in the study.
Huntsman Cancer Institute is one of three centers in the U.S. conducting this study. We expect to enroll about 140 participants.
Where Can I Get More Information?
Please reach out to the clinical trial study staff at 844-394-1126 or sch@nurs.utah.edu.