Breast Carcinoma
Conditions
Brief summary
This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
Detailed description
PRIMARY OBJECTIVE: I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. OUTLINE: Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
Interventions
OTHERQuestionnaire Administration
Ancillary studies
DEVICEMedical Device Usage and Evaluation
Wear Elasto Gel Therapy Mittens and Foot Wraps
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 in the last 10 years * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up | Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN). |
Countries
United States
Participant flow
Recruitment details
This single arm non-randomized study was conducted at Mayo Clinic in Florida. Participants included early breast cancer patients who underwent standard of care chemotherapy and who had Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no sensory peripheral neuropathy at study entry. Patients with metastatic breast cancer, Raynaud's and peripheral vascular disease, cryoglobulinemia, cold intolerance, prior exposure to neurotoxic or taxane chemotherapy were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.
Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps
Questionnaire Administration: Ancillary studies | 94 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Prevention (Elasto Gel Therapy Mittens and Foot Wraps) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 12.27 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 22 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 6 Participants |
| Race/Ethnicity, Customized White | 62 Participants |
| Region of Enrollment United States | 94 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 93 |
| other Total, other adverse events | 41 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
Primary
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)
Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).
Time frame: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
Population: Adults ages 18 and older with diagnosis of breast cancer undergoing 3 months of taxane based chemotherapy \[4 cycles of weekly paclitaxel (1 cycle = 3 weeks) or docetaxel every 3 weeks x 4-6 cycles\].
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | During chemotherapy | 41 Participants |
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | After chemotherapy | 30 Participants |
| Prevention (Elasto Gel Therapy Mittens and Foot Wraps) | Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) | 3 month follow up | 25 Participants |