Lymphedema
Conditions
Keywords
lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElaser and MLD combined
The intervention is therapist administered laser and mld treatment combined
PROCEDURElaser alone
The intervention is therapist administered laser
PROCEDUREmanual lymphatic drainage
The intervention is therapist administered manual lymphatic drainage
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Therapy Alone therapist administered laser treatment
laser: therapist administered laser | 15 |
| Mld Alone therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy | 16 |
| 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 | 15 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Laser Therapy Alone | Mld Alone | Laser and Mld Combined | Total |
|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 11.3 | 67.5 years STANDARD_DEVIATION 10.3 | 66.0 years STANDARD_DEVIATION 10.2 | 66.6 years STANDARD_DEVIATION 10.2 |
| Duration of lymphedema prior to study enrollment | 27.0 months | 18.9 months | 25.2 months | 25.4 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 15 Participants | 15 Participants | 44 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 15 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 15 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Time from surgery to lymphedema diagnosis | 7.2 months | 14.8 months | 30.0 months | 11.1 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 15 |
Outcome results
Primary
LDex Change-
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Time frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.
Population: LDex units.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laser Therapy Alone | LDex Change- | 28.0 LDex |
| Mld Alone | LDex Change- | 17.8 LDex |
| Laser and Mld Combined | LDex Change- | 22.2 LDex |
Primary
Whole Arm Volume Difference
Whole arm measurement to determine volume.
Time frame: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laser Therapy Alone | Whole Arm Volume Difference | 15.0 Whole Arm Volume % Difference |
| Mld Alone | Whole Arm Volume Difference | 6.8 Whole Arm Volume % Difference |
| Laser and Mld Combined | Whole Arm Volume Difference | 13.4 Whole Arm Volume % Difference |
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.
Time frame: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laser Therapy Alone | Quality of Life | 113.5 total score |
| Mld Alone | Quality of Life | 116.25 total score |
| Laser and Mld Combined | Quality of Life | 110 total score |
Secondary
Symptoms
Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.
Time frame: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
Population: Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laser Therapy Alone | Symptoms | 12 symptoms |
| Mld Alone | Symptoms | 12.5 symptoms |
| Laser and Mld Combined | Symptoms | 14 symptoms |