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A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia


N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms, Alopecia

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Trial Information

A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Grade III or IV alopecia according to the WHO criteria

Outcome Time Frame:

D1 of each cycle and D+21 after last cycle of chemotherapy

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Switzerland: Ethikkommission

Study ID:

DOCET_L_04449

NCT ID:

NCT01008774

Start Date:

July 2009

Completion Date:

October 2011

Related Keywords:

  • Neoplasms
  • Alopecia
  • Alopecia
  • Alopecia Areata
  • Neoplasms

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