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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081106
Recruitment Status : Withdrawn
First Posted : March 5, 2010
Last Update Posted : July 31, 2012
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Northwestern University

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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Low-Level Laser Therapy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Low-Level Laser Therapy Procedure: Low-Level Laser Therapy

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.


Primary Outcome Measures :
  1. 10 Point Scale to evaluate hair loss [ Time Frame: Photographs evaluated weekly during treatment, one month post chemotherapy ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081106

Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Principal Investigator: Jamie Van Roenn, MD Northwestern University

Responsible Party: Northwestern University Identifier: NCT01081106     History of Changes
Other Study ID Numbers: NU 09CC2
STU00021813 ( Other Identifier: Northwestern University IRB )
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Northwestern University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases