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Completed

NCT Number: NCT01351376

LLLT Combined With CDT in Breast Cancer-Related Lymphedema

This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Clinical Cancer Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
  • stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
  • girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment
  • able to commit to a long term follow-up schedule

Exclusion criteria

  • active cancer/metastatic cancer
  • currently receiving or have plans for adjuvant radiation or chemotherapy
  • pregnant
  • presence of other extremity lymphedema (primary or secondary)
  • pacemaker
  • artificial joints in the upper quadrants
  • renal failure
  • arterial insufficiency
  • congestive heart failure
  • chronic inflammatory conditions
  • history of deep vein thrombosis (DVT) in the lymphedematous upper extremity
  • previous treatment with Low Level Laser (regardless of indication)
  • medication(s) known to affect body fluid balance
  • body mass index (BMI) > 40 (morbid obesity)

Treatment and study plan

Low Level Laser Therapy

Device

Placebo LLL combined with CDT

Other names: Low Level Laser, Complex Decongestive Therapy

Low level laser

Device

Active LLL combined with CDT

Other names: Complex Decongestive Therapy

Primary outcomes

  1. Arm Volume

    Time frame: 13 Months

Secondary outcomes

  1. Short-Form Health Survey (SF-36)

    Time frame: 13 months

    Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
May 10, 2011
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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