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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laser alone | Experimental | The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response |
|
| mld alone | Active Comparator | The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response |
|
| laser and mld combined | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser and MLD combined | Procedure | The intervention is therapist administered laser and mld treatment combined |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDex Change- | Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases. | Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks. |
| Whole Arm Volume Difference | Whole arm measurement to determine volume. | Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form. | Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks. |
| Quality of Life |
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Inclusion Criteria:
Breast cancer survivors will be included if they:
Exclusion Criteria:
Individuals will not be included if they:
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| Name | Affiliation | Role |
|---|---|---|
| sheila h ridner, phd | Vanderbilt Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University School of Nursing | Nashville | Tennessee | 37240 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Therapy Alone | therapist administered laser treatment laser: therapist administered laser |
| FG001 | Mld Alone | therapist administered manual lymphatic drainage manual lymphatic drainage: therapist administered massage therapy |
| FG002 | Laser and Mld Combined | therapist administered laser and mld Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
breast cancer survivors with known lymphedema
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Therapy Alone | therapist administered laser treatment laser: therapist administered laser |
| BG001 | Mld Alone | therapist administered manual lymphatic drainage manual lymphatic drainage: therapist administered massage therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDex Change- | Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases. | LDex units. | Posted | Median | Inter-Quartile Range | LDex | Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks. |
|
Participants were followed through the last treatment and there was an average of 9 treatments per group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser Therapy Alone | therapist administered laser treatment laser: therapist administered laser No adverse events during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila H, Ridner, PHD | Vanderbilt University School of Nursing | 615-322-0831 | Sheila.Ridner@Vanderbilt.edu |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D008405 | Massage |
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| laser alone | Procedure | The intervention is therapist administered laser |
|
| manual lymphatic drainage | Procedure | The intervention is therapist administered manual lymphatic drainage |
|
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. |
| Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. |
| BG002 | Laser and Mld Combined | therapist administered laser and mld Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time from surgery to lymphedema diagnosis | Median | Inter-Quartile Range | months |
|
| Duration of lymphedema prior to study enrollment | Median | Inter-Quartile Range | months |
|
| OG002 | Laser and Mld Combined | therapist administered laser and mld Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment |
|
|
| Secondary | Symptoms | Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form. | Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome. | Posted | Median | Inter-Quartile Range | symptoms | Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks. |
|
|
|
| Secondary | Quality of Life | 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. | Posted | Median | Inter-Quartile Range | total score | Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. |
|
|
|
| Primary | Whole Arm Volume Difference | Whole arm measurement to determine volume. | Posted | Median | Inter-Quartile Range | 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. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Mld Alone | therapist administered manual lymphatic drainage manual lymphatic drainage: therapist administered massage therapy No adverse events during the study. | 0 | 16 | 0 | 16 |
| EG002 | Laser and Mld Combined | therapist administered laser and mld Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment No adverse events during the study. | 0 | 15 | 0 | 15 |
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D064746 |
| Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |