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Cryocompression to Reduce Chemotherapy-Induced Peripheral Neuropathy in Patients with Gynecologic Cancer
Trial Status: active
This clinical trial tests whether cyrocompression may prevent or reduce peripheral neuropathy in patients receiving chemotherapy. Many patients experience peripheral neuropathy after receiving chemotherapy. This may include numbness, tingling and pain in the hands and feet. Cryotherapy is the treatment of the hands and feet with cold temperatures using ice bags. Compression therapy is the treatment of the hands and feet with surgical compression gloves and compression socks. Cryocompression is a combination of the above two therapies. Giving compression to the hands and feet while receiving chemotherapy may help reduce the amount of peripheral neuropathy that patients experience.
Inclusion Criteria
Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or fine need aspiration [FNA] in conjunction with radiologic impression will be eligible)
Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks or 5 cycles of cisplatin weekly at Duke Cancer Institute at Duke Women’s Cancer Care Raleigh. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided
Exclusion Criteria
Treated with prior neurotoxic chemotherapeutic agents
Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud’s disease
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04563130.
I. Determine if cryocompression therapy prevents or reduces peripheral neuropathy in patients receiving chemotherapy, both with patient-reported outcomes and an objective clinical measure.
SECONDARY OBJECTIVE:
I. Determine if cryocompression therapy is acceptable and tolerable to patients.
OUTLINE:
Beginning 15 minutes before chemotherapy, patients undergo cyrocompression to either the dominant or non-dominant hand and foot for the duration of chemotherapy until 15 minutes after completion of chemotherapy.
After completion of study treatment, patients are followed up at 30 days.
