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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-23

Study Completion Date

2018-10-05

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy.

II. To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to topical cryotherapy in this study situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply bags filled with crushed ice to hands and feet for 15 minutes before, for 60 minutes during administration, and for 15 minutes after finishing administration of paclitaxel.

ARM II: Patients receive paclitaxel intravenously (IV) over 60 minutes on weeks 1-12.

In both arms, courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 30 days for 6 months.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Cryotherapy

Applied topically

Intervention Type PROCEDURE

Paclitaxel

Given IV

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No