Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000671
- Jacksonville, Florida: 16-000671
NCT ID: NCT02640053
Sponsor Protocol Number: RU221511I
About this study
This randomized pilot clinical trial studies topical cryotherapy (a procedure in which an extremely cold liquid is used to freeze and destroy abnormal tissue) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy may help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.
Participation eligibility
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.
Inclusion Criteria:
- Ability to complete questionnaires by themselves or with assistance
- Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient has score of 0 or 1 on the neurotoxicity evaluation, as determined by the healthcare provider
Exclusion Criteria:
- Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
- Diagnosis of fibromyalgia
- Any prior exposure to neurotoxic chemotherapy
- History of Raynaud's disease, cryoglobulinemia
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Charles Loprinzi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Charles Loprinzi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available