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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: 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
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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. administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Photographs evaluated weekly during treatment, one month post chemotherapy

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Robert H. Lurie Cancer Center
• Investigators: Principal Investigator: Jamie Van Roenn, MD, Northwestern University

Study record dates

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NU 09CC2; STU00021813 (Other Identifier: Northwestern University IRB)