search
Back to results

Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-Level Laser Therapy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must have breast cancer and must be starting chemotherapy with Adriamycin or a taxane-based therapy.
  • Participants must be 18 years old or older
  • Participants must be female
  • Participant must agree to comply with therapeutic and follow-up schedule.
  • Patient must signed informed consent form.

Exclusion Criteria:

  • Participants cannot have sensitivity to the laser light.
  • Participants cannot have used any topical or oral products to grow hair within 3 months of enrollment to this study.
  • Participants cannot be pregnant, lactating or planning on pregnancy during therapeutic schedule.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Low-Level Laser Therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    10 Point Scale to evaluate hair loss
    The primary objective is to evaluate the ability of Low-Level Laser Therapy (LLLT) to prevent chemotherapy induced alopecia in women receiving adjuvant chemotherapy for breast cancer.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2010
    Last Updated
    July 30, 2012
    Sponsor
    Northwestern University
    Collaborators
    Robert H. Lurie Cancer Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01081106
    Brief Title
    Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer
    Official Title
    Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northwestern University
    Collaborators
    Robert H. Lurie Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to see whether low level laser therapy can help maintain normal hair growth on the scalp in people receiving chemotherapy, which is generally associated with hair loss.
    Detailed Description
    Chemotherapy is a common treatment given to patients with breast cancer. Many chemotherapy drugs cause rapid hair loss. While hair loss is temporary, this side effect is a significant concern for patients. Low level laser therapy has been shown to help make hair grow. It is hoped that it may stop hair loss from occurring. Participants will be receiving 20 to 30 minute laser sessions to their scalp twice a week beginning two weeks before treatment begins until one week past the last chemotherapy session. . Photographs will be taken during each study participant's initial visit, during treatment visits, and one month following the final chemotherapy treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Breast Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-Level Laser Therapy
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Low-Level Laser Therapy
    Intervention Description
    A LLLT device at 670 nm will be used for light application using lasers affixed in a rotating helmet apparatus. Treatment will be given twice weekly prior to commencing chemotherapy and will be administered once a week until one week after the last chemotherapy. administration.
    Primary Outcome Measure Information:
    Title
    10 Point Scale to evaluate hair loss
    Description
    The primary objective is to evaluate the ability of Low-Level Laser Therapy (LLLT) to prevent chemotherapy induced alopecia in women receiving adjuvant chemotherapy for breast cancer.
    Time Frame
    Photographs evaluated weekly during treatment, one month post chemotherapy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must have breast cancer and must be starting chemotherapy with Adriamycin or a taxane-based therapy. Participants must be 18 years old or older Participants must be female Participant must agree to comply with therapeutic and follow-up schedule. Patient must signed informed consent form. Exclusion Criteria: Participants cannot have sensitivity to the laser light. Participants cannot have used any topical or oral products to grow hair within 3 months of enrollment to this study. Participants cannot be pregnant, lactating or planning on pregnancy during therapeutic schedule.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jamie Van Roenn, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer

    We'll reach out to this number within 24 hrs