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Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer

Primary Purpose

Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold Cap Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented informed consent of the participant
  • Age: >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) =< 2
  • Ability to read and understand English or Spanish for questionnaires
  • Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
  • A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane
  • At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair
  • Willing to be contacted for brief annual assessments for five years
  • Women of childbearing potential (WOCBP): negative urine pregnancy test

  • Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study

    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Exclusion Criteria:

  • Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
  • A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
  • Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
  • Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
  • Any cutaneous scalp metastases
  • Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
  • Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
  • A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
  • Evidence of untreated or poorly controlled hyper or hypothyroidism
  • American Society of Anesthesiologist Class >= 3
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Pregnant or breastfeeding
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Supportive care (PSCS)

    Arm Description

    Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.

    Outcomes

    Primary Outcome Measures

    Success in hair preservation
    Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: > 0 - 25%; grade 2: > 25 - 50%; grade 3: > 50 - 75%; grade 4: > 75%). Hair preservation was defined as hair loss no more than grade 2.

    Secondary Outcome Measures

    Incidence of adverse events of PSCS
    Will be determined by spontaneous reporting of adverse events and negative scalp changes determined by physical examination. Frequency tables will be used to summarize these events.
    Burden on nurses and infusion center team
    The workload impact will be assessed via surveys distributed to nurses, and descriptive analysis will be used to explore the collected data.
    Tolerability of PSCS
    Will be determined by the proportion of patients who completed all planned cycles of chemotherapy using the PSCS will be assessed (including 95% CI).
    Hair loss recovery
    Patient self-assessment of hair loss at each chemotherapy infusion.
    Patients quality of life
    Will be measured by EORTC-QLQ-30 quality of life questionnaire. Changes will be summarized descriptively and comparison with baseline will be carried out using paired t-test (or non-parametric paired test when suitable). In addition, repeated measures one-way ANOVA will also be used where appropriate to evaluate changes over time.

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    January 31, 2023
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05533320
    Brief Title
    Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer
    Official Title
    Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decided to withdraw
    Study Start Date
    December 14, 2022 (Anticipated)
    Primary Completion Date
    November 14, 2023 (Anticipated)
    Study Completion Date
    November 14, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.
    Detailed Description
    PRIMARY OBJECTIVE: I. Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer. SECONDARY OBJECTIVES: I. Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS. III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment. OUTLINE: Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions. After completion of study, patients are followed up for 1 year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supportive care (PSCS)
    Arm Type
    Experimental
    Arm Description
    Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.
    Intervention Type
    Device
    Intervention Name(s)
    Cold Cap Therapy
    Other Intervention Name(s)
    Cold Cap, Paxman Scalp Cooling System, PSCS, Scalp Cooling, Scalp Cryotherapy, Scalp Hypothermia
    Intervention Description
    Undergo scalp cooling
    Intervention Type
    Other
    Intervention Name(s)
    Quality-of-Life Assessment
    Other Intervention Name(s)
    Quality of Life Assessment
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Success in hair preservation
    Description
    Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: > 0 - 25%; grade 2: > 25 - 50%; grade 3: > 50 - 75%; grade 4: > 75%). Hair preservation was defined as hair loss no more than grade 2.
    Time Frame
    At 4 weeks after completion of the 6th chemotherapy cycle
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events of PSCS
    Description
    Will be determined by spontaneous reporting of adverse events and negative scalp changes determined by physical examination. Frequency tables will be used to summarize these events.
    Time Frame
    At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy
    Title
    Burden on nurses and infusion center team
    Description
    The workload impact will be assessed via surveys distributed to nurses, and descriptive analysis will be used to explore the collected data.
    Time Frame
    Up to 1 year
    Title
    Tolerability of PSCS
    Description
    Will be determined by the proportion of patients who completed all planned cycles of chemotherapy using the PSCS will be assessed (including 95% CI).
    Time Frame
    Up to 1 year
    Title
    Hair loss recovery
    Description
    Patient self-assessment of hair loss at each chemotherapy infusion.
    Time Frame
    Up to 1 year
    Title
    Patients quality of life
    Description
    Will be measured by EORTC-QLQ-30 quality of life questionnaire. Changes will be summarized descriptively and comparison with baseline will be carried out using paired t-test (or non-parametric paired test when suitable). In addition, repeated measures one-way ANOVA will also be used where appropriate to evaluate changes over time.
    Time Frame
    Up to 30 days after the last dose of treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented informed consent of the participant Age: >= 18 years Eastern Cooperative Oncology Group (ECOG) =< 2 Ability to read and understand English or Spanish for questionnaires Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair Willing to be contacted for brief annual assessments for five years Women of childbearing potential (WOCBP): negative urine pregnancy test Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only) Exclusion Criteria: Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy Exposure to other investigational agents, drugs, device or procedure that may cause hair loss Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale Any cutaneous scalp metastases Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens Evidence of untreated or poorly controlled hyper or hypothyroidism American Society of Anesthesiologist Class >= 3 Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures Pregnant or breastfeeding Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James R Waisman
    Organizational Affiliation
    City of Hope Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer

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