Peripheral Neuropathies
Conditions
Brief summary
To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities
Detailed description
This is a therapeutic study investigating the use of cryotherapy in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) and associated nail toxicities. The therapeutic intervention will involve patients wearing an Elasto-Gel cold glove and sock on one hand and one foot (both on the right side or both on the left side). The patients will wear the glove and sock during each infusion of taxane chemotherapy.
Interventions
DEVICECryotherapy
An Elasto gel™ frozen (4°C) glove and sock
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of early stage breast cancer (stage I-III). * Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy. * Age \> 18 years. There is no upper age limit for participation in this study. * Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation. * Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs) * All patients will have given signed, informed consent prior to registration * Patients must have a performance status of ECOG 0 or 1.
Exclusion criteria
* Patients must not have received any prior taxane or platinum based chemotherapy. * Patients must not have a history of peripheral neuropathy (regardless of cause). * Patient must not have a history of Raynaud's disease. * Patients with partial or complete limb amputations. * Known hypersensitivity to cold * Patient cannot be on the following medications: GABA analogues (such as Neurontin, lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline) * As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements. * Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participant in the clinical trial * Must not be pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Peripheral Neuropathy During Taxane Chemotherapy | Change from baseline to 6 months post chemo (up to 14 months) | A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing no pain and 100mm representing pain as bad as it could possibly be. The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity. |
| Evaluate Safety of Cryotherapy Use | Baseline to 6 months post Cryotherapy (up to 14 months) | Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryotherapy Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cryotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Evaluate Safety of Cryotherapy Use
Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes
Time frame: Baseline to 6 months post Cryotherapy (up to 14 months)
Population: Only 8 of the subjects were evaluable for adverse events of Grade 3 or higher, and not all data from all time points was available due to suspension of research activities during the pandemic
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryotherapy | Evaluate Safety of Cryotherapy Use | 0 Number of Adverse Events |
Primary
Prevention of Peripheral Neuropathy During Taxane Chemotherapy
A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing no pain and 100mm representing pain as bad as it could possibly be. The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Time frame: Change from baseline to 6 months post chemo (up to 14 months)
Population: Only 7 of the subjects were evaluable, and not all data from all time points was available due to suspension of research activities during the pandemic
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cryotherapy | Prevention of Peripheral Neuropathy During Taxane Chemotherapy | 7.28 score on a scale |