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

NCT01081106 | Withdrawn DMC

• 2 other identifiers: NU 09CC2STU00021813
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Low-Level Laser Therapy

OTHER

Procedure: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy PROCEDURE

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.

Low-Level Laser Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Cancer Center: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Jamie Van Roenn, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 5, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07