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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01081106
First received: February 19, 2010
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Procedure: Low-Level Laser Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 10 Point Scale to evaluate hair loss [ Time Frame: Photographs evaluated weekly during treatment, one month post chemotherapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081106

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

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01081106     History of Changes
Other Study ID Numbers: NU 09CC2, STU00021813
Study First Received: February 19, 2010
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Breast Cancer

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

ClinicalTrials.gov processed this record on May 23, 2013