Breast CancerPhase 2NCT02230319
Prevention of Paclitaxel Neuropathy With Cryotherapy
A Phase 2 study testing Cryotherapy and Paclitaxel in people with Breast Cancer, run by Medical Oncology & Hematology Associates of Northern Virginia at 2 sites in United States.
Trial summary
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryotherapy and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Mar 2017
- Phase
- Phase 2
- 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 18 years of age or older
- Histologically or cytological proven diagnosis of breast cancer Stage I- III.
- Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.
- May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Patient signed informed consent.
- Patient willing and able to comply with scheduled visits and treatment plan.
Who cannot join
- Patient presents with Grade 2 or greater peripheral neuropathy.
- History of Raynaud's Disease.
- Patient presents open or poorly-healing wounds on the hands or feet.
- Patients with cold intolerance.
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, 22031
Medical Oncology & Hematology Associates of Northern Virginia
Reston, Virginia, 20190
About this study
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
- Conditions
- Breast Cancer
- Being tested
- Cryotherapy, Paclitaxel
- Keywords
- Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Also called Cold therapy, Elasto gel™
PaclitaxelDrug
Also called Taxol, Taxanes
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes. Receives: Other: Cryotherapy; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Measured: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Secondary outcomes (1)
Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
Measured: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Oncology & Hematology Associates of Northern Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Inova Health Care Services
- Responsible party
- Principal investigator, Mary Wilkinson, Medical Oncology & Hematology Associates of Northern Virginia
- Investigators
- Mary J Wilkinson, MD, Principal investigator, Medical Oncology & Hematology Associates of Northern Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230319
- Sponsor's protocol ID
- 2014.1
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Paclitaxel Neuropathy With Cryotherapy
- ClinicalTrials.gov ID
- NCT02230319
- Acronym / sponsor ID
- 2014.1
- Conditions
- Breast Cancer
- Keywords
- Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical Oncology & Hematology Associates of Northern VirginiaUniversity, hospital or other
- Collaborators
- Inova Health Care Services
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Sep 2014 (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.
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: Cryotherapy, Drug: PaclitaxelEach patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women 18 years of age or older
- Histologically or cytological proven diagnosis of breast cancer Stage I- III.
- Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.
- May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Key exclusion criteria (5 listed)
- Patient presents with Grade 2 or greater peripheral neuropathy.
- History of Raynaud's Disease.
- Patient presents open or poorly-healing wounds on the hands or feet.
- Patients with cold intolerance.
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
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 |
|---|---|---|
| CryotherapyAlso: Cold therapy, Elasto gel™ | Other | Cryotherapy |
| PaclitaxelAlso: Taxol, Taxanes | Drug | Cryotherapy |
Primary outcome
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Time frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
1 secondary outcome
Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
Time frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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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.
Mary J Wilkinson, MD principal investigator
Medical Oncology & Hematology Associates of Northern Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryotherapy and Paclitaxel in people with Breast Cancer, run by Medical Oncology & Hematology Associates of Northern Virginia at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel. (time frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.). 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 1 Oct 2015.