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OpenTrials
Completed

NCT Number: NCT01008774

START: Swiss Taxotere Alopecia Prevention Trial

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

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Key information

Conditions

Neoplasms Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paxman Cooling Machine

Device

Scalp cooling procedures

Cold Caps

Device

Scalp cooling procedures

Primary outcomes

  1. Grade III or IV alopecia according to the WHO criteria

    Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy

Secondary outcomes

  1. Compliance to scalp cooling procedure

    Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy

  2. Side effects of scalp cooling systems

    Time frame: D1 of each cycle and D+21 after last cycle of chemotherapy

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 6, 2009
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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