AzTrials
AzTrials

Chemotherapy AdjuvantNCT01831024

Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

A study testing Dignicap System in people with Chemotherapy Adjuvant and Breast Cancer, run by Target Health Inc. at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Chemotherapy Adjuvant, Breast Cancer
What is being tested?
Dignicap System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
4 sitesUnited States
Study dates
Jul 2013to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Beth Israel Medical Center, Comprehensive Cancer Center

    New York, New York, 10011

  • Weill Cornell Breast Center

    New York, New York, 10065

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Being tested
Dignicap System
Keywords
Cold cap, Scalp cooling, Chemotherapy induced alopecia, Breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dignicap SystemDevice

    Also called Cold cap

    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.

Study groups in NCT01831024
Study groupRoleWhat they receive
Treatment GroupExperimentalDignicap System
Receives: Device: Dignicap System
Control GroupNo interventionConcurrent age and chemotherapy matched control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hair loss

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

    Measured: 4 weeks after last chemotherapy cycle

Secondary outcomes (4)

  1. Tolerability

    The percentage of patients who complete all planned cycles of chemotherapy do so using the DigniCap™ System

    Measured: Every 2 to 4 weeks for up to 12 weeeks

  2. Adverse events

    spontaneous reporting by the patient or identified during physical examination

    Measured: 6 months

  3. Hair regrowth

    Patient assessment using hair regrowth survey

    Measured: 4 Weeks after last chemotherapy

  4. Quality of Life

    European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire

    Measured: 4 Weeks after last chemotherapy cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831024
Sponsor's protocol ID
DIG-001
Status last verified
Oct 2016
First submitted
3 Apr 2013
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28196257

Questions about this trial

What is this clinical trial studying?

A study testing Dignicap System in people with Chemotherapy Adjuvant and Breast Cancer, run by Target Health Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair loss (time frame: 4 weeks after last chemotherapy cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831024, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in