NCT03712696: DIGNICAP

Efficacy and Safety of DIGNICAP™ System

Completed NA Last updated 19 October 2018

What this trial tests

NA trial testing DIGNICAP™ in Breast Cancer in 139 participants. Completed in 20 September 2018.

Timeline

18 July 2014

Primary endpoint
30 April 2018

20 September 2018

Quick facts

Lead sponsor	European Institute of Oncology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	139
Start date	18 July 2014
Primary completion	30 April 2018
Estimated completion	20 September 2018
Sites	1 location across Italy

Drugs / interventions tested

• DIGNICAP™

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Chemotherapy-induced Alopecia — all drugs for Chemotherapy-induced Alopecia →

Sponsor

European Institute of Oncology

Who can join

18 and older, female only, with Breast Cancer or Chemotherapy-induced Alopecia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevention and Treatment of Chemotherapy-Induced Alopecia: What Is Available and What Is Coming?
   Wikramanayake TC, Haberland NI, Akhundlu A, Laboy Nieves A, et al · · 2023 · cited 37× · PMID 37185388 · DOI 10.3390/curroncol30040275
2. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines.
   Munzone E, Bagnardi V, Campennì G, Mazzocco K, et al · · 2019 · cited 25× · PMID 31303642 · DOI 10.1038/s41416-019-0520-8