Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

NCT ID: NCT01831024

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment Group

Dignicap System

Group Type: EXPERIMENTAL

Dignicap System

Intervention Type: 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.

Control Group

Concurrent age and chemotherapy matched control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cold cap

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Target Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Beth Israel Medical Center, Comprehensive Cancer Center

New York, New York, United States

Weill Cornell Breast Center

New York, New York, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28196257 (View on PubMed)

Other Identifiers

DIG-001

Identifier Type: -

Identifier Source: org_study_id