START: Swiss Taxotere Alopecia Prevention Trial

Sanofi239 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

239

Conditions

Neoplasms Alopecia

Interventions

Paxman Cooling MachineDEVICE

Scalp cooling procedures

Cold CapsDEVICE

Scalp cooling procedures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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