A Study to Evaluate Cryotherapy to Prevent Taxane-induced Sensory Neuropathy of the Hands and Feet
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 19-008929
NCT ID: NCT04256512
Sponsor Protocol Number: 19-008929
About this study
The purpose of this study is to evaluate the effectiveness and tolerability of cryotherapy (cold therapy) in the form of Elasto Gel® frozen mittens and foot wraps to determine whether or not they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. The hypothesis of our pilot study is that patients receiving cryotherapy during infusion of taxane therapy will have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Patients ≥ 18 years of age with a diagnosis of breast cancer.
- Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks).
- Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Ability to complete questionnaires by themselves or with assistance.
- Ability to give signed informed consent.
- History of prior sensory/motor peripheral neuropathy from any cause.
- History of prior Raynaud's phenomenon.
- History of cryoglobulinemia.
- Active peripheral vascular disease.
- Cold intolerance.
- Prior exposure to neurotoxic chemotherapy.
- Hand-foot syndrome.
- Tumor metastasis in bone, soft tissue, or skin of the hands or feet.
- Absence of one or more fingers or toes.
- Prior exposure to taxane chemotherapy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available