Overview

Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome

Status:
Completed
Trial end date:
2018-10-05
Target enrollment:
0
Participant gender:
All
Summary
This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with ice bags) 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 is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Academic and Community Cancer Research United
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
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