Chemotherapeutic Agent ToxicityNCT01243541
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
A study testing cryotherapy, questionnaire administration and quality-of-life assessment in people with Chemotherapeutic Agent Toxicity and Pain, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Pain, Peripheral Neuropathy
- What is being tested?
- cryotherapy, questionnaire administration and quality-of-life assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2010to 4 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically confirmed diagnosis of breast cancer (any stage)
- Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy
- Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals
- 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
- Required lab values: CBC, Comprehensive Chemistry Panel
- Desired lab values: If the patient's record also includes TSH, HbA1c, and folate, then those will be recorded as well
- All patients will have given signed, informed consent prior to registration
Who cannot join
- Patients must not have received any prior taxane treatments
- Patients must not have a history of peripheral neuropathy (regardless of cause)
- Patient must not have a history of diabetes mellitus
- Patient must not have a history of Raynaud's disease
- Men are not eligible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.
Read the detailed description
PRIMARY OBJECTIVES: I. Differences in "tingling" and "numbness" (measured on 0-10 numeric rating scale; as measured by NPSI) between treated and untreated extremities at conclusion of paclitaxel therapy). SECONDARY OBJECTIVES: I. Differences in nail toxicity between treated and untreated extremities as measured by NCI-CTC v4.0 from baseline to conclusion of taxane therapy and at each time point (after each infusion and at conclusion of taxane therapy). II. Differences in peripheral sensory neuropathy subscale of NCI-CTC v 4.0 between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). III. Differences in pain intensity (0-10 from BPI) between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). IV. Differences in quantitative sensory testing between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM I. Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. ARM II: Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. In both arms, treatment repeats every 2 weeks for 4 courses in the absences of unacceptable toxicity.
- Conditions
- Chemotherapeutic Agent Toxicity, Pain, Peripheral Neuropathy, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- Being tested
- cryotherapy, questionnaire administration, quality-of-life assessment, management of therapy complications, assessment of therapy complications
- Medical subject headings
- Pain, Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
Patients wear an Elasto-Gel cold glove and sock
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.
assessment of therapy complicationsProcedure or surgery
Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. Receives: Procedure: cryotherapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Procedure: assessment of therapy complications |
| Arm II | Experimental | Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. Receives: Procedure: cryotherapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Procedure: assessment of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities.
Measured: Periodically during study treatment
To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.
Measured: After completion of study treatment
Secondary outcomes (1)
To compare the treated and untreated extremities at each time point with respect to the ratings in regards to the NCI-CTC v4.0, BPI, and QSTs.
Measured: Periodically during study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study start3 Nov 2010
- Primary completion4 Apr 2014
- Study completion4 Apr 2014
Why it stopped: PI decision due to low accrual and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Judith Paice, PhD, RN, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243541
- Sponsor's protocol ID
- NU 10CC03
- Other IDs
- NCI-2010-02105, STU00033028
- Status last verified
- Aug 2019
- First submitted
- 29 Oct 2010
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
- ClinicalTrials.gov ID
- NCT01243541
- Acronym / sponsor ID
- NU 10CC03
- Conditions
- Chemotherapeutic Agent Toxicity, Pain, Peripheral Neuropathy, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decision due to low accrual and lack of funding
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2010 (actual)
- Primary completion
- 4 Apr 2014 (actual)
- Study completion
- 4 Apr 2014 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.
Detailed description
PRIMARY OBJECTIVES: I. Differences in "tingling" and "numbness" (measured on 0-10 numeric rating scale; as measured by NPSI) between treated and untreated extremities at conclusion of paclitaxel therapy). SECONDARY OBJECTIVES: I. Differences in nail toxicity between treated and untreated extremities as measured by NCI-CTC v4.0 from baseline to conclusion of taxane therapy and at each time point (after each infusion and at conclusion of taxane therapy). II. Differences in peripheral sensory neuropathy subscale of NCI-CTC v 4.0 between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). III. Differences in pain intensity (0-10 from BPI) between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). IV. Differences in quantitative sensory testing between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM I. Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. ARM II: Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. In both arms, treatment repeats every 2 weeks for 4 courses in the absences of unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: cryotherapy, Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: management of therapy complications, Procedure: assessment of therapy complicationsPatients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. |
| Arm II | Experimental | Procedure: cryotherapy, Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: management of therapy complications, Procedure: assessment of therapy complicationsPatients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with histologically confirmed diagnosis of breast cancer (any stage)
- Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy
- Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals
- 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
Key exclusion criteria (5 listed)
- Patients must not have received any prior taxane treatments
- Patients must not have a history of peripheral neuropathy (regardless of cause)
- Patient must not have a history of diabetes mellitus
- Patient must not have a history of Raynaud's disease
- Men are not eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapyPatients wear an Elasto-Gel cold glove and sock | Procedure or surgery | Arm I, Arm II |
| questionnaire administrationAncillary studies | Other | Arm I, Arm II |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I, Arm II |
| management of therapy complicationsAlso: complications of therapy, management ofIn this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems. | Procedure or surgery | Arm I, Arm II |
| assessment of therapy complicationsStudy Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day. | Procedure or surgery | Arm I, Arm II |
Primary outcome
To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities.
Time frame: Periodically during study treatment
To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.
Time frame: After completion of study treatment
1 secondary outcome
To compare the treated and untreated extremities at each time point with respect to the ratings in regards to the NCI-CTC v4.0, BPI, and QSTs.
Time frame: Periodically during study treatment
Results and safety
The study was stopped early (reason given: PI decision due to low accrual and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Paice, PhD, RN principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy, questionnaire administration and quality-of-life assessment in people with Chemotherapeutic Agent Toxicity and Pain, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI decision due to low accrual and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities. (time frame: Periodically during study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.