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Withdrawn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
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer
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.
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
NCT ID
NCT01081106
First Posted
February 19, 2010
Last Updated
July 30, 2012
Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
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Withdrawn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
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Study Completion Date
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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
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Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer
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