Efficacy and Safety of DIGNICAP™ System

NCT03712696 | Completed

• 1 other identifier: IEO 0075/
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Chemotherapy-induced Alopecia

Outcome Measures

Primary Outcomes (1)

• Reduction of hair loss

  Hair loss (HR) assessed by the patient herself after completing the last cycle of chemotherapy (21 days after last CT infusion) using photographs taken 5 angles using a VAS (Visual Analogue Scale) (Grade 0: no hair loss; Grade 1: \< 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75% of hair loss; Grade 4: \>75% of hair loss)

  21 days

Secondary Outcomes (6)

• Hair loss assessed by physician

  21 days

• Assessment of head/scalp pain

  21 days

• Assessment of feeling chilled

  21 days

• Assessment of patient satisfaction

  21 days

• Assessment of patient symptoms

  21 days

Study Arms (1)

DIGNICAP™

EXPERIMENTAL

DigniCap® System

Device: DIGNICAP™

Interventions

DIGNICAP™ DEVICE

Scalp cooling to prevent chemotherapy-induced alopecia

DIGNICAP™

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 18 years of age Performance status (ECOG) 0- 1
• Documented diagnosis of stage I or II breast cancer
• A planned course of chemotherapy in the adjuvant setting with curative intent including one of the following regimens:
• Doxorubicin 60 mg/m2 or Epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks
• Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks
• Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
• Docetaxel 75-100 mg/m2 IV every 3 weeks x 4 cycles with or without trastuzumab IV weekly or every 3 weeks
• Targeted agents such as trastuzumab are allowed
• Patients receiving a regimen including both an anthracycline and a taxane (at doses reported above) are also eligible for this trial (AC/T, EC/T, TAC, etc.)
• Plan to complete chemotherapy within 6 months
• 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
• Negative pregnancy test (in fertile women).

You may not qualify if:

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Previous chemotherapy
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
• A history of whole brain radiation
• Concurrent hormone therapy with chemotherapy except LHRH analogue. 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Related Publications (1)

• Munzone E, Bagnardi V, Campenni G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. 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. Br J Cancer. 2019 Aug;121(4):325-331. doi: 10.1038/s41416-019-0520-8. Epub 2019 Jul 15.

  PMID: 31303642 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisabetta Munzone, MD

  IEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 19, 2018
• Study Start: July 18, 2014
• Primary Completion: April 30, 2018
• Study Completion: September 20, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

IT (1)