Stanford Lymphedema Registry

kira66715

Dr. Rockson told me that it was delayed, but all sorts of security protocols were implemented, and now it is live. It does involve medical information from the patients, but has the potential to really figure out some of the root causes of LE.

https://breastcancer-lymphedema.stanford.edu/login

It has been clarified for me that the registry is going to focus on women with breast cancer and no LE yet, but it will also accept patients with LE.

Kira

carol57

Kira, to help Dr. Rockson, might you consider a post outside of the LE forum, to explain a bit about LE risk after BC treatment and why participating in Dr. Rockson's registry will have long-term benefit to the entire BC-survivor community?  If he needs women who had BC but not LE, I wonder how many of the tens of thousands of women using bc.org will learn of it if they are not already here in the LE forum.  Or see if Dr. Rockson might approach BC.org about a special post from him.  Just a thought.

Carol 

kira66715

Carol, that's a great thought. He had sent me the link, then clarified that it is a prospective study. I tried to register and had issues. I want to get on it before I disseminate it widely, and see if it can be useful to those of us with LE.

I did ask him about when his latest studies will be in print--but haven't heard.

Kira

carol57

Kira, Just the other day I went to that site, before you posted here, to look at the registry procedure. I saw that it was a bit involved and just bookmarked it to register later.  Now I understand from you that it's not intended for those of us with an LE diagnosis.

I'm preparing LE materials for a resource packet that our local Komen chapter gives to women with new BC diagnoses in four counties, so I am mulling over the thought of a short 'you can help' piece explaining LE risk, and including information about the registry. Also we have a visiting onc in our little town, and she is very supportive of LE education.  I can approach her about making available to her patients info about the registry.  This would work so much better if Dr. Rockson had a half-page handout in pdf format to explain the registry and also including his and his center's research credentials.

The registry is such a wonderful idea!  I hope we can all help by encouraging eligible women to participate.

Carol 

carol57

Kira, I had a chance to go over Dr. Rockson's earlier research report with my PharmD niece, who helped me with language describing the properties of ketoprophen.  Dr. Rockson found ketoprophen to be effective in reversing induced LE in the tails of research mice.  Niece translated the 'how it works' part, which I will not attempt to paraphrase here.  I should have been taking notes, but I did not.

But what is easy enough to relay is what she told me about the history of the drug.  It was formerly an over the counter NSAID, marketed as Orudis KT and as Actron. In about 2006, the non-prescription-strength versions of the drug were removed from the market by their makers (Wyeth and Bayer) and subsequently private label versions manufactured by Perrigo were no longer marketed either.

Niece told me that she understands the manufacturers found there just wasn't market appetite for the OTC version of the drug. Ibuprophen seemingly met the need for this type of OTC NSAID.  It continues to be available in prescription strength.  Here is an explanation I found online, posted by a consultant to the pharma industry:

While there were 4 reports of GI bleeding with use of ketoprofen, according to FDA, the product was not discontinued due to safety concerns and is eligible for market reintroduction. Prescription doses are still on the market. Here is an excerpt from the Federal Register regarding this subject:

The agency has determined that ORUDIS KT (ketoprofen) tablets, 12.5 mg, were not withdrawn from sale for reasons of safety or effectiveness. The petitioner referenced, among other information, certain labeling changes intended to assist consumers in the safe use of the drug, and some adverse event reports. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has determined that this product was not withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA determines that, for the reasons outlined in this notice, ORUDIS KT (ketoprofen) tablets, 12.5 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list ORUDIS KT (ketoprofen) tablets, 12.5 mg, in the ‘‘Discontinued Drug Product List'' section of the Orange Book. The ‘‘Discontinued Drug Product List'' delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to ORUDIS KT (ketoprofen) tablets, 12.5 mg, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.

My niece tells me that in prescription strength, the drug is approved for use for a very limited course of treatment, only five days. She was wondering if any use of the drug for LE treatment would be effective in such a limited time frame, or if Dr. Rockson's research would lead to an altered version of the drug to permit longer term administration.

I hope he releases his new study results soon!

Carol 

kira66715

Okay, I did the registry--I was told it was designed to track women who did not yet have LE, but if you did, you could click to enter more information after the initial intake.

I found the registry a bit difficult to complete: they want the names of all the treating physicians, and then when I clicked to enter more information, I got first the general health screen and then a LE series of questions popped up. It presumes your MD diagnosed your LE. There was no screen to enter explanations.

So, I filled it all out, and we'll see.

The instructions I got from Stanford, for women who already had LE were: the research project was designed primarily to investigate the impact of early detection measures for lymphedema vs. current standards-of-care. Accordingly, the information flow (and the design of the interface) presumes that the subject is initially breast cancer positive/lymphedema negative, and tracks the patient at 3 month intervals from that point. For anyone who is already lymphedema positive, at the end of the first encounter, there is an option to click, in order to enter more information. When doing that, there is a repeat SF-36 form, followed by questions about the interval development of lymphedema. It would make the most sense to do this, in order to track the lymphedema and its treatment.

They do ask who treats your LE, and how much money you've spent on it. It asks about 3 months intervals--because ideally women are filling this out at the start of treatment, so I just answered positively for what I've experienced in the last 3 months and how much I've spent on LE.... 

Carol: I looked up ketoprofen and it is not the safest drug out there. Wondering also how long it would be safe to use it. The dosing is 50 to 100 mg three times a day.

Kira 

beacon800

I signed up.  Hope I did it right.  I don't have any LE.  My interest is to help in any way I can to understand more about who gets LE and how to help them.  One of my really big anxieties about surgery was the fear of LE and that fear influenced my behavior the past two years.  I wish there were more information for everyone.

carol57

Kira,  I drew the same conclusion about ketoprophen after talking with my family pharmacy expert: the short course --5 days or less--is designed to limit risk.  It will be very interesting to see where Dr. Rockson takes this, because 5 days seems hardly likely to 'cure' LE (that would be the miracle cure, no?).  It also makes me wonder again what prompted him to try this drug in the first place.  I hope the studies to be released soon are available to the public.

Beacon, did the registry ask you to describe a cancer diagnosis?  I too had LCIS, which coupled with a bodacious family history led me to the pbmx that delivered the gift of LE.  I am wondering if the study considers LCIS or PLCIS to be cancer.  It happens that a disagreement between my diagnostic med center and my surgical center led to a sentinel node biopsy, which turned out to be clear, and is the likely suspect in my LE.  But I still wonder if the registry will use my data if there was no official cancer diagnosis.    It's great that you completed the survey.  We all wish there was more information out there.  Whether Dr. Rockson's registry and studies lead to a cure/prevention or not, at least he's gathering data to help understand the $%#! condition better.

Carol 

kira66715

Carol, they don't ask you for any clinical information--just the name of your treating doctors and a release to get your clinical information.