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

• ClinicalTrials.gov Identifier: NCT01081106
• Recruitment Status: Withdrawn
• First Posted: March 5, 2010
• Last Update Posted: July 31, 2012
• Sponsor: Northwestern University
• Collaborator: Robert H. Lurie Cancer Center
• Information provided by (Responsible Party): Northwestern University

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Low-Level Laser Therapy	Not Applicable

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 Design

• 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

Arms and Interventions

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. administration.

Outcome Measures

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.

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Northwestern University

Robert H. Lurie Cancer Center

Investigators

• Principal Investigator: Jamie Van Roenn, MD; Northwestern University

More Information

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT01081106
• Other Study ID Numbers: NU 09CC2; STU00021813 ( Other Identifier: Northwestern University IRB )
• First Posted: March 5, 2010
• 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; Neoplasms; Breast Diseases; Skin Diseases