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Riancorp LTU-904 Laser Therapy

Measurement and definition of lymphedema: bioimpedance, surveys, perometry, measurement

Compression Garments on Airplanes

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The True Incidence of Lymphedema

Research Updates and Comments

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Risk Reduction
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Riancorp LTU-904 Laser Therapy

Low level laser therapy (LLLT) has been introduced into the US market for lymphedema. In 2006 the FDA cleared the Riancorp low level laser device for lymphedema treatment.* The Riancorp LTU-904 laser therapy units are infra-red lasers operating at a wavelength of 904 nanometers. This invisible wavelength penetrates deeply into tissue where it is absorbed by cells and converted into energy that apparently aids in reducing the swelling of post mastectomy lymphedema.

Very small studies suggest that low-level laser therapy may be effective in reducing lymphedema in a clinically meaningful way for some women. Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately one-third of patients with post-mastectomy lymphedema at three months post-treatment. Suggested rationales for laser therapy include a potential decrease in fibrosis, stimulation of macrophages and the immune system, and a possible role in encouraging lymphangiogenesis.

We researched these studies and found the laser has been tested in one trial on 64 women with either one or two cycles, delivered by therapists, and the women were followed for 3 months. This is the placebo controlled, double blind study that was the basis for granting FDA approval. Unfortunately, we can not find any studies in the world literature where larger numbers of women were followed for longer periods of time.

Treatment of postmastectomy lymphedema with low-level laser therapy: a double blind, placebo-controlled trial. Carati CJ, Anderson SN, Gannon BJ, Piller NB. Department of Anatomy, School of Medicine, Flinders University, Adelaide, South Australia, Australia. colin.carati@flinders.edu.au BACKGROUND: The current study describes the results of a double blind, placebo-controlled, randomized, single crossover trial of the treatment of patients with postmastectomy lymphedema (PML) with low-level laser therapy (LLLT). METHODS: Participants received placebo or one cycle or two cycles of LLLT to the axillary region of their affected arm. They were monitored for reductions in affected limb volume, upper body extracellular tissue fluid distribution, dermal tonometry, and range of limb movement. RESULTS: There was no significant improvement reported immediately after any of the treatments. However, the mean affected limb volume was found to be significantly reduced at 1 month or 3 months of follow-up after 2 cycles of active laser treatment. Approximately 31% of subjects had a clinically significant reduction in the volume of their PML-affected arm (> 200 mLs) approximately 2-3 months after 2 cycles of treatment. There was no significant effect of placebo treatment, or one cycle of laser treatment, on affected limb volume. The extracellular fluid index of the affected and unaffected arms and torso were reported to be significantly reduced at 3 months after 2 cycles of laser therapy, and there was significant softening of the tissues in the affected upper arm. Treatment did not appear to improve range of movement of the affected arm. CONCLUSIONS: Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately 33% of patients with postmastectomy lymphedema at 3 months after treatment. Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11641

We have found another study where it was tested on ten woman:

Treatment of chronic postmastectomy lymphedema with low level laser therapy: a 2.5 year follow-up.

Piller NB, Thelander A.

Department of Public Health, School of Medicine, Flinders Medical Centre, Bedford Park, South Australia. binbp@flinders.edu.au

Ten women with unilateral arm lymphedema after axillary clearance (radical mastectomy) and radiotherapy for breast cancer received 16 treatment sessions with Low Level Laser Therapy (LLLT) over 10 weeks and seven patients were followed for 36 months. The effect of LLLT was monitored by arm circumference, plethysmography, tonometry, bioimpedance and a questionnaire dealing with subjective symptoms. After treatment, edema volume (both extracellular and intracellular) was decreased, the tissue (except for the upper arm) progressively softened or approached a normal texture, and the patients reported improvement in aches/pains, tightness, heaviness, cramps, pins/needles, and mobility of the arm. Skin integrity was also improved and the index for risk of infection decreased. Follow-up assessment at 1, 3, 6, and 30-36 months showed varying trends although at 30-36 months most subjective parameters and bioimpedance derived data on ECF and ICF tended to return toward pre-treatment levels. Arm circumference continued to show overall improvement, however, with a volume reduction of the affected arm reaching 29%. Tonometry also showed maintenance of near normal values for the involved forearm and anterior and posterior chest; however, the upper arm showed progressive induration. The data suggest that laser treatment, at least initially, improved most objective and subjective parameters of arm lymphedema

The laser is available for purchase by individuals to use in their home: please note the caution on their brochure.

Precautions

As with any clinical modality for treatment of lymphedema, treatment only should commence after consultation with the patient's oncologist or appropriate medical specialist.

The clinical trial used to support marketing did not evaluate the safety or effectiveness of the device beyond two treatment blocks (i.e., two cycles of treatment administered every 2 days (three times a week) for three weeks. Increasing the amount of treatment time or frequency of treatment will not necessarily improve the results.

Ann Angel
Executive Director
7 Fleet St Richmond
South Australia SA 5033
p +61 8 8232 8822 f +61 8 8232 8833

We would like to see a large study of many women, followed for years after its use, with clinical guidelines.. Now that the laser is used in many clinics, we would like to have data on the clinical experience that has resulted from its use.

Here is a link to what the National Cancer Institute has to say about low level laser therapy:

Low-level laser therapy

Studies suggest that low-level laser therapy may be effective in reducing lymphedema in a clinically meaningful way for some women.[17] Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately one-third of patients with postmastectomy lymphedema at 3 months post-treatment.[17] Suggested rationales for laser therapy include a potential decrease in fibrosis, stimulation of macrophages and the immune system, and a possible role in encouraging lymphangiogenesis.[17]

As a patient, you can report problems with any device or medication to the FDA. If you have used the low level laser therapy and have had adverse effects, please report these adverse effects to the FDA at their consumer website.

The fact that the FDA has "cleared" a particular product, like the laser, does not mean the FDA has "approved" it. FDA approval requires more substantial research evidence that a product is safe and effective. Unfortunately, the FDA may "clear" a product as a treatment method without clear evidence that the product is effective or safe for the intended use.

The 510 (K) process was never intended to be utilized for the majority of medical devices that the FDA clears, as it requires no study or proof of safety or effectiveness, but due to multiple factors the 510 (K) process is now utilized in 98% of medical devices that are cleared for sale and use by the FDA.

Here is a link to the congressional testimony of Diane Zuckerman PhD, President of the National Research Center for Women and Families on the 510 (K) process: http://www.center4research.org/news/6-12-07mdufa.html

This testimony offers an comprehensive explanation of the 510 (K) process for medical devices.

"The small number of women studied and the fact that the research was funded by the company that makes and sells the laser raise questions about the reproducibility of the results. The laser may be effective, but that can only be proven when it has been tested in controlled trials on larger numbers of patients, preferably with funding from an independent source."

*Regarding FDA approval of medical devices under 510(k) review, we quote from the New York Times, October 27, 2008:

* * *

"The nation's system for regulating medical devices was set up more than three decades ago, when devices played a much smaller role in medicine. A growing chorus of doctors, consumer advocates and health insurance executives say it is overdue for an overhaul.
The process has become "a barrier to evidence development," said Dr. Winifred S. Hayes, whose firm, Hayes Inc., evaluates new health care technologies.

Although federal drug regulation dates back more than 100 years, medical devices did not come under the government's purview until 1976, after Congress responded to deaths linked to the Dalkon Shield, an intrauterine contraceptive device.

Because the new law would not apply to devices on the market before 1976, Congress did not want makers of newer products to be at a competitive disadvantage. So lawmakers provided the quick review process for any new product deemed "substantially equivalent" to something already on the market. That expedited process became known as a 510(k) review under the relevant section of the law.

But critics say that what Congress intended as a way to let simple devices quickly enter the market has expanded so much that even critical therapies are cleared without enough research.

'It is supposed to be for the Band-aids of the world," said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington advocacy group. "The 510(k) process should have been used less and less. It's being used more.'

* * *"

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Measurement and definition of lymphedema: bioimpedance, surveys, perometry, measurement
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Compression Garments on Airplanes
Controversial Study on Wearing Compression Garments While Flying Coming out of SABCS, December, 2008
A controversial study has come out of the San Antonio Breast Cancer Symposium, December, 2008. Air Travel Holds Little Lymphedema Risk for Breast Cancer Survivors.
Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Also note these prior studies: Lymphedema initiated by aircraft flights. Casley-Smith JR, Casley-Smith JR. Henry Thomas Laboratory, University of Adelaide, S.A., Australia. Precipitating factors in lymphedema : Myths and realities, Author, ROCKSON S. G

Here's the press release:

http://www.medpagetoday.com/MeetingCoverage/SABCS/12142

A study was presented at the 2008 San Antonio Breast Cancer Symposium (SABCS) about the risk of lymphedema when flying. A news release about that study came out in the on-line newsletter, MedPageToday.

According to the news release, the study found that women who've had breast cancer surgery "need not worry" about developing lymphedema when flying.

But, that isn't what the researchers said in their report. The results and conclusions in their SABCS meeting abstract (Abstract #1119) are different from what the news release says. Here's a link to a page with a search engine that can be used to type in the abstract number and access the abstract of the study: http://www.abstracts2view.com/sabcs/sessionindex.php

The study involved 75 women who had recovered from breast cancer surgery and were flying to Queensland, Australia, to participate in a dragon boat regatta.   The researchers used "bioimpedance" to measure extracellular fluid in the arms of the women before and after the airplane flights.

One problem with the study is that bioimpedance was the only method the researchers used to see if the women had developed lymphedema. Some lymphedema researchers and clinicians think bioimpedance might not be sensitive enough to detect lymphedema until it reaches a severe form (Stage III). So, swelling that was less severe might not have been detected in this study.

According to the news release in MedPage Today, 5% of the women in the study did develop a "clinically significant" increase in arm fluid, as judged by bioimpedance. Five percent seems like enough of a risk to warrant taking precautions when flying. What is odd is that the researchers reported a different number in their abstract--not 5%--for the prevalence of "clinically significant" arm fluid. They said 15 of the 75 women developed a "clinically significant" increase; and 15 of 75 is 20%, not 5%. Twenty percent is considerable risk. Most women would probably think a risk of 20% was worth "worrying about," and worth taking precautions.

But not all the women in the study were at equal risk of developing lymphedema. Of the 75 women, 12 took fairly short flights to Queensland from other locations in Australia. Only one of those 12 women had a "clinically significant" accumulation of arm fluid. The other 63 women in the study flew all the way to Australia from Canada, which was a much longer flight--a "long haul" flight, according to the researchers. Among the 63 women who took the trans-oceanic flights, 14 had a "clinically significant" increase in arm fluid. So, the women on the longer flights had a 14/63 = 22% chance of developing a "clinically significant" increase in arm fluid. That number would likely attract most women's attention and cause them concern.

According to the researchers, 8 of the 15 women who had a "clinically significant" increase in arm fluid had enough of an increase for it to be diagnostic of lymphedema (i.e., they actually developed lymphedema). All 8 of those women were on the flights from Canada. That means 8/63 = 12.7% of the women who took the trans-oceanic flights developed bona fide lymphedema in association with their flights. The news release said all but 2 of those women had been diagnosed with lymphedema previously. That statement implies that lymphedema triggered by flying is somehow less important if it is a recurrence than if it is a new case. In contrast to that statement in the news release, the number of new cases reported in the abstract was much higher. The researchers said in their abstract that 6 of the 8 women diagnosed with bona fide lymphedema in association with the flight had not had arm swelling prior to the flight--this was a new diagnosis of lymphedema for them.

Finally, the news release failed to emphasize an important point: The women in this study were traveling to Australia to participate in a dragon boat regatta. According to the researchers, 94% of the women in the study had "trained at a moderate to vigorous intensity for the regatta."   We can probably assume they were in pretty good shape--their upper-body conditioning was likely much better than that of most women after breast cancer treatment. Several studies have shown that a supervised exercise program involving upper-body strength training can reduce the risk of lymphedema after breast cancer surgery. Wouldn't that mean the women in this study were at lower risk of developing lymphedema in the first place? So, why would the news release mislead their readers by generalizing the findings to all women?

The first sentence in the news release says, "Women who've had breast cancer surgery need not worry that pressure changes in an airplane cabin will bring on lymphedema, researchers found." But that's very different from what the researchers concluded in their abstract. Here's what the abstract said:   "For the majority of women who undertake moderate to vigorous upper limb exercise, airplane travel did not have a significant impact on extracellular fluid ratio."
Those two statements mean very different things. The discrepancies in representation of the results of this study are troubling, and should be clarified for the benefit of all women who have been treated for breast cancer and are facing the risk of lymphedema.
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Exercise
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The True Incidence of Lymphedema

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Page Last Modified 01/21/2010