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Efficacy and Safety of DIGNICAP™ System

NCT03712696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2018-10-19

No results posted yet for this study

Summary

Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy.

In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT).

A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years.

The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.

Conditions

Interventions

DEVICE

DIGNICAP™

Scalp cooling to prevent chemotherapy-induced alopecia

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Elisabetta Munzone, MD · IEO

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-18
Primary Completion
2018-04-30
Completion
2018-09-20

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712696 on ClinicalTrials.gov