LymphedemaPhase 4NCT00852930
Low Level Laser Treatment and Breast Cancer Related Lymphedema
A Phase 4 study testing laser and MLD combined, laser alone and manual lymphatic drainage in people with Lymphedema, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- laser and MLD combined, laser alone and manual lymphatic drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer survivors will be included if they:
- are age 21 or older;
- require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
- have an order for lymphedema treatment; and
- are willing and able to drive to the study sites.
Who cannot join
- Individuals will not be included if they:
- are actively undergoing intravenous chemotherapy or radiation therapy;
- have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
- are unable to stand upright for measurement of height and weight;
- have active/metastatic cancer;
- are pregnant,:
- have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University School of Nursing
Nashville, Tennessee, 37240
About this study
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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- laser and MLD combined, laser alone, manual lymphatic drainage
- Keywords
- lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser and MLD combinedProcedure or surgery
The intervention is therapist administered laser and mld treatment combined
laser aloneProcedure or surgery
The intervention is therapist administered laser
manual lymphatic drainageProcedure or surgery
The intervention is therapist administered manual lymphatic drainage
| Study group | Role | What they receive |
|---|---|---|
| laser alone | Experimental | The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response Receives: Procedure: laser alone |
| mld alone | Active comparator | The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response Receives: Procedure: manual lymphatic drainage |
| 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 Receives: Procedure: laser and MLD combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDex Change-
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Measured: 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.
Measured: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
Secondary outcomes (2)
Symptoms
Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.
Measured: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
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.
Measured: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt University
- Investigators
- sheila h ridner, phd, Principal investigator, Vanderbilt Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852930
- Sponsor's protocol ID
- 090118
- Status last verified
- Apr 2017
- First submitted
- 26 Feb 2009
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Treatment and Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT00852930
- Acronym / sponsor ID
- 090118
- Conditions
- Lymphedema
- Keywords
- lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laser alone | Experimental | Procedure: laser aloneThe intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response |
| mld alone | Active comparator | Procedure: manual lymphatic drainageThe intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response |
| laser and mld combined | Experimental | Procedure: laser and MLD combinedThe intervention was therapist administered low level laser and mld using low level laser and standard massage techniques, number of sessions based upon patient response |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are age 21 or older;
- require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
- have an order for lymphedema treatment; and
- are willing and able to drive to the study sites.
Key exclusion criteria (8 listed)
- are actively undergoing intravenous chemotherapy or radiation therapy;
- have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
- are unable to stand upright for measurement of height and weight;
- have active/metastatic cancer;
- are pregnant,:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser and MLD combinedThe intervention is therapist administered laser and mld treatment combined | Procedure or surgery | laser and mld combined |
| laser aloneThe intervention is therapist administered laser | Procedure or surgery | laser alone |
| manual lymphatic drainageThe intervention is therapist administered manual lymphatic drainage | Procedure or surgery | mld alone |
Primary outcome
LDex Change-
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.
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Whole Arm Volume Difference
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.
Whole arm measurement to determine volume.
2 secondary outcomes
Symptoms
Time frame: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sheila h ridner, phd principal investigator
Vanderbilt Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laser and MLD combined, laser alone and manual lymphatic drainage in people with Lymphedema, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDex Change- (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.