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.|
|ClinicalTrials.gov Identifier: NCT01081106|
Recruitment Status : Withdrawn
First Posted : March 5, 2010
Last Update Posted : July 31, 2012
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Low-Level Laser Therapy||Not Applicable|
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|
|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|
|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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01081106
|Principal Investigator:||Jamie Van Roenn, MD||Northwestern University|
|Responsible Party:||Northwestern University|
|Other Study ID Numbers:||
STU00021813 ( Other Identifier: Northwestern University IRB )
|First Posted:||March 5, 2010 Key Record Dates|
|Last Update Posted:||July 31, 2012|
|Last Verified:||July 2012|
Neoplasms by Site