Low Level Laser Treatment and Breast Cancer Related Lymphedema

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Vanderbilt University

JARIBIO LA KLINIKI: NCT00852930

BioSeek: nct00852930

Maneno muhimu

Kikemikali

Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.

Maelezo

The purpose of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with related LE. Findings from this pilot randomized study will be used to determine if LLLT has possible value in the treatment of LE and warrants subsequent evaluation in a larger study.

Tarehe

Imethibitishwa Mwisho:	03/31/2017
Iliyowasilishwa Kwanza:	02/25/2009
Uandikishaji uliokadiriwa Uliwasilishwa:	02/25/2009
Iliyotumwa Kwanza:	02/26/2009
Sasisho la Mwisho Liliwasilishwa:	04/06/2017
Sasisho la Mwisho Lilichapishwa:	04/10/2017
Tarehe ya matokeo ya kwanza yaliyowasilishwa:	07/16/2015
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa:	09/29/2015
Tarehe ya matokeo ya kwanza kuchapishwa:	10/31/2015
Tarehe halisi ya kuanza kwa masomo:	08/31/2009
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	03/31/2012
Tarehe ya Kukamilisha Utafiti:	03/31/2012

Hali au ugonjwa

Lymphedema

Uingiliaji / matibabu

Procedure: laser and mld combined

Procedure: laser alone

Procedure: mld alone

Awamu

Awamu 4

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: laser alone The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response	Procedure: laser alone The intervention is therapist administered laser
Active Comparator: mld alone The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response	Procedure: mld alone The intervention is therapist administered manual lymphatic drainage
Experimental: laser and mld combined The intervention was therapist administered low level laser and mld using low level laser and standard massage techniques, number of sessions based upon patient response	Procedure: laser and mld combined The intervention is therapist administered laser and mld treatment combined

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	21 Years Kwa 21 Years
Jinsia Inastahiki Kujifunza	Female
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: Breast cancer survivors will be included if they: 1. are age 21 or older; 2. require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology; 3. have an order for lymphedema treatment; and 4. are willing and able to drive to the study sites. Exclusion Criteria: Individuals will not be included if they: 1. are actively undergoing intravenous chemotherapy or radiation therapy; 2. have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb; 3. are unable to stand upright for measurement of height and weight; 4. have active/metastatic cancer; 5. are pregnant,: 6. have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or 7. have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.

Matokeo

Hatua za Matokeo ya Msingi

1. LDex Change- [Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.]

Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.

2. Whole Arm Volume Difference [Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.]

Whole arm measurement to determine volume.

Hatua za Matokeo ya Sekondari

1. Symptoms [Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.]

Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.

2. Quality of Life [Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.]

The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.