NeoplasmsNCT01008774
START: Swiss Taxotere Alopecia Prevention Trial
A study testing Paxman Cooling Machine and Cold Caps in people with Neoplasms and Alopecia, run by Sanofi at 1 site in Switzerland.
Trial summary
Primary objective: Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading) Secondary objective: Compliance to scalp cooling procedure Received number of cycles of chemotherapy in each subgroup Patient perception of scalp cooling procedure Side effects of scalp cooling systems Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Paxman Cooling Machine and Cold Caps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Oct 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
- Performance Status ECOG <= 2
- Absence of alopecia at inclusion
Who cannot join
- Chemotherapy regimen including concomitant anthracycline treatment
- Raynaud's disease or phenomenon
- Cold agglutinin disease
- Cryoglobulinemia
- Cryofibrinogenemia
- Scalp metastasis
- Pregnancy or Lactation
- Preexisting alopecia of any grade; notably androgenetic alopecia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Primary objective:
- Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)
Secondary objective:
- Compliance to scalp cooling procedure
- Received number of cycles of chemotherapy in each subgroup
- Patient perception of scalp cooling procedure
- Side effects of scalp cooling systems
- Being tested
- Paxman Cooling Machine, Cold Caps
- Medical subject headings
- Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Cooling MachineDevice
Scalp cooling procedures
Cold CapsDevice
Scalp cooling procedures
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Paxman Cooling Machine |
| B | Active comparator | Not described Receives: Device: Cold Caps |
| C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III or IV alopecia according to the WHO criteria
Measured: D1 of each cycle and D+21 after last cycle of chemotherapy
Secondary outcomes (2)
Compliance to scalp cooling procedure
Measured: D1 of each cycle and D+21 after last cycle of chemotherapy
Side effects of scalp cooling systems
Measured: D1 of each cycle and D+21 after last cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008774
- Sponsor's protocol ID
- DOCET_L_04449
- Status last verified
- Jan 2012
- First submitted
- 1 Oct 2009
- Last updated
- 23 Jan 2012
- Results posted
- No
Publications
Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
PubMed 23636645
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
- ClinicalTrials.gov ID
- NCT01008774
- Acronym / sponsor ID
- DOCET_L_04449
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Nov 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.
Primary objective:
- Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)
Secondary objective:
- Compliance to scalp cooling procedure
- Received number of cycles of chemotherapy in each subgroup
- Patient perception of scalp cooling procedure
- Side effects of scalp cooling systems
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Paxman Cooling Machine |
| B | Active comparator | Device: Cold Caps |
| C | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
- Performance Status ECOG <= 2
- Absence of alopecia at inclusion
Key exclusion criteria (8 listed)
- Chemotherapy regimen including concomitant anthracycline treatment
- Raynaud's disease or phenomenon
- Cold agglutinin disease
- Cryoglobulinemia
- Cryofibrinogenemia
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 |
|---|---|---|
| Paxman Cooling MachineScalp cooling procedures | Device | A |
| Cold CapsScalp cooling procedures | Device | B |
Primary outcome
Grade III or IV alopecia according to the WHO criteria
Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy
2 secondary outcomes
Compliance to scalp cooling procedure
Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy
Side effects of scalp cooling systems
Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy
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 23 Jan 2012.
- Derived from this study: PubMed 23636645Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paxman Cooling Machine and Cold Caps in people with Neoplasms and Alopecia, run by Sanofi at 1 site in Switzerland.
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 3 inclusion and 8 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 23 Jan 2012. 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 Switzerland. 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 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?
Grade III or IV alopecia according to the WHO criteria (time frame: D1 of each cycle and D+21 after last cycle of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008774, which also lists 1 linked publication.
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 23 Jan 2012.