Low Level Laser Treatment and Breast Cancer Related Lymphedema

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Prisijungti Registracija

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StatusasBaigta

Rėmėjai

Vanderbilt University

KLINIKINIS TYRIMAS: NCT00852930

BioSeek: nct00852930

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta:	03/31/2017
Pirmasis pateikimas:	02/25/2009
Numatytas registravimas pateiktas:	02/25/2009
Pirmas paskelbtas:	02/26/2009
Paskutinis atnaujinimas pateiktas:	04/06/2017
Paskutinis atnaujinimas paskelbtas:	04/10/2017
Pirmųjų rezultatų pateikimo data:	07/16/2015
Pirmojo QC rezultatų pateikimo data:	09/29/2015
Pirmųjų paskelbtų rezultatų data:	10/31/2015
Faktinė studijų pradžios data:	08/31/2009
Numatoma pirminio užbaigimo data:	03/31/2012
Numatoma studijų užbaigimo data:	03/31/2012

Būklė ar liga

Lymphedema

Intervencija / gydymas

Procedure: laser and mld combined

Procedure: laser alone

Procedure: mld alone

Fazė

Fazė 4

Rankų grupės

Ranka	Intervencija / gydymas
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

Tinkamumo kriterijai

Amžius, tinkami studijuoti	21 Years Į 21 Years
Tinkamos studijoms lytys	Female
Priima sveikus savanorius	Taip
Kriterijai	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.

Rezultatas

Pirminės rezultatų priemonės

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.

Antrinės rezultatų priemonės

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.