Breast NeoplasmsPhase 3CRYO1NCT00925418
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
A Phase 3 study testing Frozen Glove in people with Breast Neoplasms and Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Prostate Cancer, Nail Diseases
- What is being tested?
- Frozen Glove
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Jul 2011
- Phase
- Phase 3
- 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
- Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
- Patients aged 18 and older
- Nail toxicity < grade 2 (CTC-AE version 3.0)
- Informed patients with signed consent
Who cannot join
- History of treatment with taxane
- Raynaud syndrome
- Distal metastasis in superior extremity
- Nail diseases
- Distal arteriopathy
- Cold intolerance
Show all 10Show fewer
- Peripheral neuropathy>=2
- Pregnancy, breast feeding
- Unable to give informed consent
- Unable to have a medical follow-up for social, geographical, family or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.
Primary objective:
Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.
Secondary objectives:
Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove
- Conditions
- Breast Neoplasms, Prostate Cancer, Nail Diseases
- Being tested
- Frozen Glove
- Keywords
- Neoplasm, breast Neoplasm, docetaxel, Glove
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Nail Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen GloveProcedure or surgery
Using frozen glove during chemotherapy with Taxotere®
| Study group | Role | What they receive |
|---|---|---|
| Without Glove | No intervention | Patients do not use frozen glove during chemotherapy with Taxotere® |
| With Glove | Experimental | Patients use frozen glove during chemotherapy with Taxotere® Receives: Procedure: Frozen Glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
Measured: 4 months
Secondary outcomes (3)
Number of day between inclusion and apparition of nail toxicity
Measured: 4 months
Necessity of local care, existence of pains
Measured: 4 months
Tolerance and compliance for the frozen glove
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole TARPIN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925418
- Sponsor's protocol ID
- CRYO 1/IPC 2005-007
- Acronym
- CRYO1
- Status last verified
- Sep 2011
- First submitted
- 19 Jun 2009
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00925418
- Acronym / sponsor ID
- CRYO1 / CRYO 1/IPC 2005-007
- Conditions
- Breast Neoplasms, Prostate Cancer, Nail Diseases
- Keywords
- Neoplasm, breast Neoplasm, docetaxel, Glove
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jun 2009 (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.
Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.
Primary objective:
Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.
Secondary objectives:
Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Glove | No intervention | –Patients do not use frozen glove during chemotherapy with Taxotere® |
| With Glove | Experimental | Procedure: Frozen GlovePatients use frozen glove during chemotherapy with Taxotere® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
- Patients aged 18 and older
- Nail toxicity < grade 2 (CTC-AE version 3.0)
- Informed patients with signed consent
Key exclusion criteria (10 listed)
- History of treatment with taxane
- Raynaud syndrome
- Distal metastasis in superior extremity
- Nail diseases
- Distal arteriopathy
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 |
|---|---|---|
| Frozen GloveUsing frozen glove during chemotherapy with Taxotere® | Procedure or surgery | With Glove |
Primary outcome
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
Time frame: 4 months
3 secondary outcomes
Number of day between inclusion and apparition of nail toxicity
Time frame: 4 months
Necessity of local care, existence of pains
Time frame: 4 months
Tolerance and compliance for the frozen glove
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
- Official web site of the sponsorLink provided by the sponsor.
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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.
Carole TARPIN, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Frozen Glove in people with Breast Neoplasms and Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 14 Sep 2011. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0) (time frame: 4 months). 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 14 Sep 2011.