Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

NCT01831024 | Unknown DMC

• 1 other identifier: DIG-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chemotherapy Adjuvant; Breast Cancer

Keywords

Cold cap; Scalp cooling; Chemotherapy induced alopecia; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Hair loss

  5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia

  4 weeks after last chemotherapy cycle

Secondary Outcomes (4)

• Tolerability

  Every 2 to 4 weeks for up to 12 weeeks

• Adverse events

  6 months

• Hair regrowth

  4 Weeks after last chemotherapy

• Quality of Life

  4 Weeks after last chemotherapy cycle

Study Arms (2)

Treatment Group

EXPERIMENTAL

Dignicap System

Device: Dignicap System

Control Group

NO INTERVENTION

Concurrent age and chemotherapy matched control

Interventions

Dignicap System DEVICE

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.

Also known as: Cold cap

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Target Health Inc.: lead

Study Sites (4)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Beth Israel Medical Center, Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Weill Cornell Breast Center

New York, New York, 10065, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 28196257 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 15, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (4)