Clinical trial · Interventional
START: Swiss Taxotere Alopecia Prevention Trial
A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
NCT01008774CI-TRIAL-00006112completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold Caps | Device | — | UNRESOLVED |
| Paxman Cooling Machine | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Device: Paxman Cooling Machine
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Device: Cold Caps
- type
- NO_INTERVENTION
- label
- C
Primary outcomes (1)
- measure
- Grade III or IV alopecia according to the WHO criteria
- timeFrame
- D1 of each cycle and D+21 after last cycle of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDBetticher 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. PMID 23636645