- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02640053
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center NCI Community Oncology Research Program
-
-
Michigan
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Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan NCORP
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-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Health Cancer Center
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Charleston, South Carolina, United States, 29414
- Bon Secours Saint Francis Hospital
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (topical cryotherapy, paclitaxel)
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.
Courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Applied topically
|
Active Comparator: Arm II (paclitaxel)
Patients receive paclitaxel IV over 60 minutes on weeks 1-12.
Courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale adjusting for baseline.
The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline Sensory Neuropathy subscale score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Tingling Fingers or Hands Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Tingling Toes or Feet Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Numbness Fingers or Hands Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Numbness Toes or Feet Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Fingers or Hands Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Toes or Feet Item Adjusting for Baseline
Time Frame: Up to 12 weeks
|
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your Toes or Feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much).
The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL).
The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Worst Pain (Item 1 on the Daily Post-Paclitaxel Questionnaire)
Time Frame: 1 week
|
Average Area Under the Curve (AUC) per assessment (aAUCpa) of worst pain (item 1 on the Daily Post-Paclitaxel Questionnaire; "Please rate any aches/pain that are new since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment, by circling ONE number that best describes your aches/pain at its WORST in the last 24 hours.")
over 1 week.
Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).
The aAUCpa is the average of each AUC between each sequential assessment from day 2 through 7 following paclitaxel.
|
1 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charles Loprinzi, Academic and Community Cancer Research United
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Breast Diseases
- Neuromuscular Diseases
- Breast Neoplasms
- Peripheral Nervous System Diseases
- Acute Pain
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- RU221511I (Other Identifier: Academic and Community Cancer Research United)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2015-02014 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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