Metformin-Anyone on this trial?
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Hi all,
I've noticed that around 2 pm most days I get quite tired. If I eat something I feel better. Just wondering what it is. Anyone else getting the 2pm drags.
FYI: Up here in Toronto, no one mentioned this study till I was done all treatment. Interesting, as I was almost at the one year mark when it came up as an option for me.
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Just want to chime in here-- I am not in this trial, but my onc Rx'ed Metformin, 500 mg, 2x a day and I have been taking it for about 11/2 years now. I have had absolutely NO SE's from the onset, so for those of you in the trial with no symptoms, I would not necessarily assume that you are receiving the placebo. The only thing I notice is that since taking it, I have lost about 10 lbs, but the again, I have changed my diet and cranked up my exercise regimen, so who really knows whether the metformin has played a role in the weight loss. No GI symptoms though-- and I started on the full dose right away.
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The full dose used in the clinical trial is 850mg 2x a day. I started on Metformin 2 months ago but am still taking just one 850mg tab a day since I DO have GI symptoms which I am trying to adjust to. I think it is extremely variable when it comes to who gets symptoms and who doesn't. I have a long history of IBS ever since my teens, plus continue to have a sensitive stomach these many years later which seems to just be a part of my DNA makeup. I am looking forward to early trial reports so I can decide whether or not to bite the bullet and go with the full dose. If symptoms don't get a lot worse it may be tolerable but for now I am sticking with just one 850mg pill a day.
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I am also on this trial... Started before my last chemo in November, had the wonderful SE of the bathroom being my best best friend... and Still do one in a while.... I have been slacking taking them latley as we have been very busy and doing alot of travelling so to take it and end up needing to GO..... while driving on the highway well lets just say would not be funny..... This was recommended by my medical onco... So why not try it right.....
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Linda - do you know when the early trial reports will be released?
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Oaktownmom, No I don't. I sure hope we hear something in early 2013 though. If clinical trials are going well with good outcomes, early reports are not uncommon, but it also depends on the trial researchers. The Metformin and breast cancer trial started in July 2010 and is due to end in June 2016. Hearing some type of preliminary study results half-way through the trial, which would mean 2013, would be great.
http://clinicaltrials.gov/ct2/show/NCT01101438?term=NCT01101438&rank=1
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Thanks Momoschki, you've given me hope! : )
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I am not on the clinical trial either as I already have diet-controlled Type 2 diabetes. But, luckily, my family doctor has given me a prescription for 850 mg 2 x a day. I had some 500 mg tablets left over from when I went through chemo so I am starting out with 1/2 tablet (250 mg) once a day and will increase the dosage as I determine that I am not having any bad SE's. Since I had triple-negative BC, there is nothing else for us to take (like Herceptin) to try to reduce recurrence - so, hopefully, this will help.
Doreen
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DorMac......How often are you increasing your dosage? I started on 250mg twice a day about a week ago with no SE's so far. I wasn't sure how often to increase the dosage.
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Rn4babies - my doctor left it up to me so I'll probably give it 2 weeks at a time, unless I find I have SE's.... but that's my own decision, not a doctor's. I have no SE's yet either.
Doreen
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I started on the study meds on 10/16. I take 1 pill a day for 28 days, and then go to 2 pills a day. So far, no SEs that I can tell. That bottle is huge - a whole 6-month supply, 400 and some pills. The research analyst said they don't expect me to use them all, even if I take all the pills I'm supposed to in that time, and I have to turn in the unused ones when I get my next supply. Is that how you are doing it too?
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Hi Indigo, yes, I've been in the study since December of last year. In May, I turned in the remainder of the bottle they gave me in December and they gave me a new big bottle. They also asked if I thought I'd missed any doses. It made me wonder if they count the returned ones to get a sense of how compliant a person has been to the study protocol.
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Couple of points in regard to above posts:
1) My clinical trial coordinator gave me a chart that's basically a calendar with 2 boxes for each day, to make sure I do take 2 a day, so yes, it sounds as if compliance is a concern.
2) I have had no SE and, at my appointment with my MO last week, I laughed and told her I KNEW I was on the placebo. She and the clinical trial coordinator said, on most trials, they can guess what the person is getting, but they said with Metformin, they've been as puzzled as the patients have. The MO said none of her patients has had side effects.
3) And yes, my initial work-up was as detailed as the one you described. My poor veins were so worn out from chemo that it was agony trying to get 8 vials. I think they finally had to pour some from one to another. Then, ONE lab result was ONE point too high for the study, although it had been within range earlier. After all that work, I was going to get into the study, come hell or high water. They let me redo that one test a few days later, and it was OK.
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I am scheduled for mastectomy on november 20, I am not sure whether to stop taking the study drug, metformin. Has anyone had surgery during this study? I will ask the doctor but wanted to plan ahead.
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I am having surgery friday and was told not to take metormin the day of surgery
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Ossa, wishing you the best with the the surgery! Sounds like you're just about done. Yes, they told me I'd have to discontinue also the day before through the day after, if I have to have a contrast scan of some kind.
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Was anyone able to get into this trial if they were treated beyond 1 year ago? I was told only open to patients treated within the past 12 months. I ask this question for those of us going off AIs who continue to have strong risk of recurrence.
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cp418: Is there any prospect of simply getting it prescribed to you? My wife is on metformin. We thought it would be a hard fight with her personal physician, but he gladly gave her a prescription for it.
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THanks Timothy - I'm going to inquire as you mentioned. I have a pancreatic cyst which is now being monitored and going on 5+ years of Femara has taken a toll on my bones. Already had 6 infusions of Zometa.....
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cp418,
I also have a strong risk of recurrence. I have been on Aromasin almost 7 years and had 11 infusions of Zometa over a 5 year period. My oncololgist has no immediate plans to stop the Aromasin, which is fine with me since my SEs are minimal. I was not eligible for the Metformin trial, but had no problems getting my PMD to prescribe it and my oncologist's approval. Other than the hopefully temporary GI symptoms and the VERY rare chance of Lactic Acidosis, Metformin has no other serious side effects I am aware of. I am currently still taking just one 850mg tab a day until my GI symptoms settle down a little better, but feel that Metformin holds much less risk than other treatments we have already taken. Hopefully, final study data will support the benefit for reducing recurrence but I feel it is worth taking now.
Would you consider switching from Femara to Aromasin if you are concerned about losing the AI coverage? The Zometa strengthening effect on the bones is supposed to last for years even after finishing the infusions. A lot of oncs are keeping their high risk patients on AIs now for an unlimited number of years until better treatments become available.
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Hi LindaLou53 - Yes - I had switched to a new Oncologist early this year when I had completed my 5 years on Femara. Exactly as you stated he recommended I stay on Femara for at least 7 years minimum due to the long term recurrence risk. I'm sticking it out on Femara as the devil I already know versus trying a different AI. I will continue taking it but am very interested in the Meformin as a backup plan especially with this new pancreatic cyst issue being monitored. It just adds to the yearly scan stress. It does seem a majority of trials are closed to patients beyond a 1 year treatment - - so I will need to discuss Metformin at my next oncologist visit in a few weeks. It is good to know that many of you are able to have your GP or oncologist write you the script. Also, I'm hoping to hear more about these AI mini-vacations where a patient is 9 months on AI with 3 months off. Goal to prevent AI drug resistance and save the joints/bones from long exposure. Fingers crossed this is covered at the end of year meeting. (toes have neuropathy so can't cross them!)
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cp418
My endo dr. Rx'd me.
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Just stumbled upon this thread and am very interested in it. Just diagnosed with early IDC September 12, but have been on 250mg's 2xdaily for about 4 years. VERY long story short (20 years of being undiagnosed and misdiagnosed) I finally found a reproductive endocrinologist who listened to me and reviewed older ultrasounds and diagnosed me with Polycystic Ovarian Syndrome. PCOS is closely tied to insulin resistance. I eat a low-carb natural diet as much as possible to go along with the metformin. My metformin combined with diet and exercise has helped me to stop losing my hair, cleared up the brown "mask" of skin on my face, given me normal pelvic ultrasounds, etc.
I'm anxious to read more here and see if I can change things a bit and accomplish two things with one treatment.0 -
Hi Dulcigirl - Welcome to the thread......So correct me if I'm wrong....you developed breast cancer despite being on Metformin for over four years??
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Well, technically yes, although I don't know how we could determine WHEN my cancer started. And also my Metformin dosage is way lower than what people are talking about here. That was why I was curious to learn more. Could upping my dosage possibly help me avoid a recurrence?
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First off I have not even had my biopsy (Oct 31st) . In this past year I have been diagnosed with type II diabetes and the a few months later cholesterol levels of over 300 and now just this past Friday with birad 4 and needing a biopsy . With my diabetes I started out with metformin at 500 mg a day then 1000 a day then went to 2000 mg a day. When I was not really responding after a few months then they put me on junuvia. When that didn't work then they have now put me on on glumetza . I just read lately that a hormone called neurotensin at high levels can cause one of these three common diseases in women..... I'm going in on Tuesday for a blood test to see in there is elevated level in my blood because within one year I come up with two and now the biopsy ...... What are the chances of all three :-(...... But hey if I do I have plenty of left over metformin !!
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What are the chances of all three :-(......
Very slim, let's hope but I have multiple health issues and learned there are no guarantees as for developing yet another one !
I am so hoping yours will come back negative.Sending good thoughts your way on Halloween!
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Hi there, I've just been an avid reader, but now have a question that I wondered if anyone could answer. I'm on the Metformin trial and do not have diabetes. My "normal" fasting blood sugar was in the low to mid 90's. My non fasting level is now 53. My MO is concerned. Is anyone else experiencing this??
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zookeeper - they should be closely watching you as too low blood glucose has significant side effects. Not certain how valid WebMD is - but you can read symptoms to watch out for.
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