Breast CancerNCT01351376
LLLT Combined With CDT in Breast Cancer-Related Lymphedema
A study testing Low Level Laser Therapy and Low Level Laser in people with Breast Cancer and Lymphedema, run by NYU Langone Health at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Low Level Laser Therapy and Low Level Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to Jul 2017
- Phase
- Interventional
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Clinical Cancer Center
New York, New York, 10016
NYU Rusk Institute of Rehabilitation Medicine
New York, New York, 10016
Tisch Hospital
New York, New York, 10016
About this study
Official 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
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.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Low Level Laser Therapy, Low Level Laser
- Keywords
- Lymphedema, Low Level Laser, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Also called Low Level Laser, Complex Decongestive Therapy
Placebo LLL combined with CDT
Low Level LaserDevice
Also called Complex Decongestive Therapy
Active LLL combined with CDT
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | CDT + inactive LLL Receives: Device: Low Level Laser Therapy |
| LLL combined with CDT | Active comparator | CDT + active LLL Receives: Device: Low Level Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Volume
Measured: 13 Months
Secondary outcomes (1)
Short-Form Health Survey (SF-36)
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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2016
- Study completionJul 2017
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Denham, PT, MA, Principal investigator, NYU Rusk Institute of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351376
- Sponsor's protocol ID
- 10-00923
- Status last verified
- Sep 2019
- First submitted
- 9 May 2011
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01351376
- Acronym / sponsor ID
- 10-00923
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Lymphedema, Low Level Laser, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: Low Level Laser TherapyCDT + inactive LLL |
| LLL combined with CDT | Active comparator | Device: Low Level LaserCDT + active LLL |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- active cancer/metastatic cancer
- currently receiving or have plans for adjuvant radiation or chemotherapy
- pregnant
- presence of other extremity lymphedema (primary or secondary)
- pacemaker
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 |
|---|---|---|
| Low Level Laser TherapyAlso: Low Level Laser, Complex Decongestive TherapyPlacebo LLL combined with CDT | Device | Placebo |
| Low Level LaserAlso: Complex Decongestive TherapyActive LLL combined with CDT | Device | LLL combined with CDT |
Primary outcome
Arm Volume
Time frame: 13 Months
1 secondary outcome
Short-Form Health Survey (SF-36)
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- 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.
Teresa Denham, PT, MA principal investigator
NYU Rusk Institute of Rehabilitation Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy and Low Level Laser in people with Breast Cancer and Lymphedema, run by NYU Langone Health at 3 sites 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 4 inclusion and 14 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2019). 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?
Arm Volume (time frame: 13 Months). 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 19 Sep 2019.