Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

Clinical Performance, Efficacy and Safety of the DigniCap™ System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer

The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle. A concurrent control group not using a cold cap will also be evaluated.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Chemotherapy Adjuvant
• Intervention / Treatment: Device: Dignicap System

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • UCSF Helen Diller Family Comprehensive Cancer Center
  • New York
    • New York, New York, United States, 10011
      • Beth Israel Medical Center, Comprehensive Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Breast Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients >/= 18 years of age
• Documented diagnosis of stage I or II breast cancer

• A planned course of chemotherapy in the adjuvant or neoadjuvant setting with curative intent including one of the following regimens:

  • Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks
  • Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 3 weeks
  • Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
  • Paclitaxel 175 mg/m2 IV every 2 weeks x 4 - 6 cycles (without an anthracycline)
  • Paclitaxel weekly and carboplatin AUC 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
  • Docetaxel 75 mg/m2 and carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
  • Targeted agents such as trastuzumab or lapatinib are allowed
• Plan to complete chemotherapy within 6 months
• At least two years out from the last chemotherapy causing hair loss with complete recovery of hair
• Karnofsky performance status >/= 80%
• Willing and able to sign informed consent for protocol treatment
• Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy
• Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment

Exclusion Criteria:

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
• A history of whole brain radiation
• Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial (AC/T, EC/T, TAC, etc.)
• Concurrent hormone therapy with chemotherapy. Hormone therapy should be used as indicated following completion of chemotherapy
• Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests >1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation.
• Clinically significant renal dysfunction defined as serum creatinine > upper limit of normal.
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss
• Intercurrent life-threatening malignancy
• A history of cold agglutinin disease or cryoglobulinemia.
• Evidence of untreated or poorly controlled hyper or hypothyroidism
• A history of silicon allergy
• American Society of Anesthesiologist Class ≥3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Dignicap System	Device: Dignicap System; The DigniCap™ System consists of the digitized system for controlled scalp cooling (Digni C3) in conjunction with the soft, tight-fitting silicon cap (DigniCap™), the neoprene outer cap (DigniTherm™), and the liquid coolant (DigniCool). DIGNISTICK™ is prepared to log data from a treatment when inserted in the slot. DIGNICARD™ is a key card which has to be inserted in order to start a treatment.; Other Names: Cold cap
No Intervention: Control Group; Concurrent age and chemotherapy matched control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair loss	5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia	4 weeks after last chemotherapy cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	The percentage of patients who complete all planned cycles of chemotherapy do so using the DigniCap™ System	Every 2 to 4 weeks for up to 12 weeeks
Adverse events	spontaneous reporting by the patient or identified during physical examination	6 months
Hair regrowth	Patient assessment using hair regrowth survey	4 Weeks after last chemotherapy
Quality of Life	European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire	4 Weeks after last chemotherapy cycle

Collaborators and Investigators

• Sponsor: Target Health Inc.

Publications and helpful links

General Publications

• Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Cold cap; Scalp cooling; Chemotherapy induced alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Breast Neoplasms; Alopecia; Alopecia Areata
• Other Study ID Numbers: DIG-001