More specifically one that was for a serious illness. I’ve been given options for my cancer treatment, one of which is a blind clinical trial. It sounds like a wonderful alternative to chemotherapy, but I’d be risking valuable time should I be unfortunate enough to be one of the placebo recipients 
I will be getting some more details before I make a decision, just wondered if anyone here has been faced with making a choice like this.
I’d write down the pros and cons of each. It may very well answer your question. I’ve done two. One I knew exactly what I was getting and I did that one. The other I won’t know and the consequences of being in the control group risks significant disability compared to other available options, but the treatment group is really getting the next level of surgical intervention. I’m not completely decided, but I’m pretty sure it’s going to be a no. I feel like the surgeon is looking at my age (difficult to find, but desirable for long term study) rather than the whole picture, so that’s one of my indirect cons playing a role.
NIH has some good guidelines for those considering participating in a clinical trial: http://www.nih.gov/health/clinicaltrials/basics.htm.
If I were in your situation, in addition to the information in the NIH link, I’d want to get real clear on the (potential) benefits of choosing a trial over a proven or traditional treatment course. What stage is my cancer and how treatable is it via surgery, chemotherapy, radiation, etc? Am I seeking alternative treatment in hopes of avoiding some unpleasant side effects (I’m absolutely not saying you are!) or for a compelling medical reason? I’d also want to know how my insurance would interact with clinical trial medicine–during and after the trial is complete. The phase of the trial is very important and may make or break my willingness to participate based on the level of my medical urgency.
Good luck with your decision.
Crash Helmet, from the NIH website “Comparing a new product with a placebo can be the fastest and most reliable way to demonstrate the new product’s therapeutic effectiveness. However, placebos are not used if a patient would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy.”
Definitely be getting clarification about this since stage 4 cancer is pretty serious!
I’ve already had one surgery, and a 2nd isn’t an option, but I’m also getting a 2nd opinion on additional radiation (or radiosurgery). I’ve also just completed 6 mos. of chemo, which didn’t slow things down, so the option other than the clinical trial is a more aggressive type of chemo (and yes, that means worse side effects than what I’ve already been through).
Toadie’s Mom -
No matter which way you go, here are some jingles for your health!
I have never participated, but I do work in the pharmaceutical industry and you are absolutely right that with a cancer trial you are likely to be either taking the investigational drug or an existing therapy - not a placebo! The trial information should make this clear, as well as what the comparator therapy is.
With respect to insurance, the clinical trial sponsor should be covering your treatment related costs, including their follow-up appointments, etc. while you are a participant in the trial. Again, this information should be made very clear to you prior to entering the trial. Trial participants are required to give informed consent, including payment information.
Late stage cancer treatment can be as much art and luck as pure science, so do your best to learn what you can and work closely with your oncologist and other doctors. Be sure they understand your feelings on how you want to manage your disease and your life - docs are great for giving you information, but remember that ultimately it is YOUR life - you get to call the shots inline with YOUR priorities.
Have not been in a clinical trial, but I do work on them for a living. I can tell you that in any good clinical trial, there is equipoise between the two arms. That means that we really do not know which arm will be better for you. Clinical trials are generally reviewed by Data Safety Monitoring Boards (DSMB) on a regular basis. If one treatment is significantly better (or worse), the DSMB will stop the trial.
It is a difficult choice. I wish you the best.
Can you chose the treatment that is being offered or is it only available through the trial? Sometimes, new treatments are available in a few places outside the trial. If it seems like the risks of the treatment are minimal, you may want to try it outside the trial if insurance will cover it. Does the clinical trial offer a crossover where the placebo group will be offered the treatment at the end of the initial study period? If so, the lost time when some are getting the placebo may be a minimal risk.
Do as much reading as you can about the proposed treatment. Google it. Read UptoDate if they have an analysis of the treatment, even if you have to go to a medical library to get their article at no charge.
I started a clinical trail a month ago at Providence in Portland OR. It is quite a drive for me, but worth it as the trial I am in has no placebo, it is a dosage trial of two immunotherapy drugs. I got the twice per month infusion plan, rather than the once per month. I could have done a clinical trial closer to home (Eugene) but all they had available was a targeted oral therapy/placebo or immunotherapy/chemo. Personally, tho I know they have to do it for the science, I feel a placebo for a stage 4 cancer patient is just cruel and it really makes me angry that it is the only option many of us have. I have already been through the chemo nightmare (three different types) and nearly died, so I have no desire to even chance that again. Good luck and I hope you find something to fit your needs.
[QUOTE=PNW AMTS Dealer;8035977]
Personally, tho I know they have to do it for the science, I feel a placebo for a stage 4 cancer patient is just cruel and it really makes me angry that it is the only option many of us have.[/QUOTE]
They don’t do placebos in this sort of case. It’s new treatment protocol vs current treatment protocol. It would be highly unethical to deny treatment to a seriously ill person.
Toadie’s Mom, I hope this works for you!
A friend of mine, stage 4 breast cancer just finished a clinical trial where the cancer spread to her lungs. Her doctor had to petition to the drug company to see if she had the drug or the placebo, and she had the placebo. So I’m not sure what you mean by “don’t do placebo’s in this type of case”.
It’s important not to confuse the terms “placebo” and “control.”
Control = group not receiving experimental treatment (but could still receive some sort of treatment such as standard of care)
Placebo = specific type of control which receives a dummy treatment (rather than standard of care)
For cancer, if there is a standard treatment available then that treatment will be used as the control.
It would be hard to imagine the FDA or hospital investigational review board (IRB) approving a strict placebo control in that situation because it would be unethical to deny a patient the standard treatment.
Where I believe that placebos can be used for cancer are in cases of rare cancers where no treatment exists or of late stage cancers where all other treatment options have been exhausted.
In those situations the patient wouldn’t have received any treatment regardless so there is no denial of care.
(There are some additional nuances where a placebo may be used as an adjunct to standard treatment, or where the patient could cross-over.)
Thanks to everyone who has responded. I have a lot of questions to bring up on Wed. when I see the research nurse, and my oncologist. Oncologist is the one who said placebo when the ct option was first brought up. Hopefully I’ll find out that he meant control instead.
I’m definitely ready to start SOMETHING! I’m losing use of my hand again, which is how this all began over a year ago. I’ve found out the hard way how much we take for granted. Can’t tie a bow, can’t fasten my bra, can’t tack up my horse, buttons are iffy. One thing that doesn’t bother me however, is how little housework I’m able to do :winkgrin:
Many jingles for you!
I’ve done 2 drug trials at MD Anderson for my advanced stage ovarian cancer. I am currently on the 2nd one. Neither involved a placebo, which would make no sense for me and my oncologist would not recommend it. In both cases, I received/am receiving the standard of care, plus an experimental drug being tested for efficacy. At MD Anderson, they explain it all in detail, including pros and cons. Just be sure you understand the details clearly before making decision. As you undoubtedly know, with advanced-stage cancers like you and I have, there comes a time when you must balance the treatment impacts (good and bad) against your quality of life. Best of luck and keep us posted!
I was in remission for a while. When things changed and I was going back on drugs, they encouraged a clinical trial. They knew the drug was effective, this would have helped with dosing etc.
I read thru the trial paperwork and found the parameters to be incredibly intrusive on living my life so I decided NOT to do it.
I worked in the pharma industry so know how important CTs are but the time asked for in this was just going to get in the way of enjoying life. 12 hour blood sample days once a month. You could not be away more than 12 days in a row. Not for me.
My brother BIL has pancreatic cancer and did the Whipple procedure. after which they asked if he would join a vaccine group, which he did. Fast forward several years. He was incredibly healthy and doing great. They opened the code and found he was in the control (untreated) group and beating the odds fantastically
Read the trial details and let that help you make an informed decision
Do not hesitate to ask ANY question you have about how it affects YOU
Best of luck
My clinical trial is also inconvenient and time consuming, especially since I cannot drive 2.5 hours straight due to my vertigo, so I have to have a driver. I have been making this trip once per week for 5 weeks thru phase one. While I get my infusion they take my blood pressure and temperature every 15 minutes, the first couple treatments they also took blood three times throughout the day and also three EKG’s. I begin phase 2 on wednesday, after that I only have to make the trip twice per month. We leave about 6 am and get home about 5pm and 5 hours of that is driving. I hate it, it is exhausting, but it is the only option I had that I felt comfortable with. I’ve done radiation, chemo and an oral chemo targeted therapy. It will be two years in may since my diagnosis. I’ve already outlived the odds I was given. I’m only 45 and not ready to give up. So we trudge on and try and make the best of a bad situation. My husband takes me to most of my appointments. Sometimes we take our travel trailer and spend the night so the next day we can find a nice hiking trail. This trip we are going on up to washington to meet a dog at the inmate prison dog training program. I’m hoping to meet my new best friend and save life.
Ok, enough rambling. I wish you all the best in whatever you choose.
My clinical trial is also inconvenient and time consuming, especially since I cannot drive 2.5 hours straight due to my vertigo, so I have to have a driver. I have been making this trip once per week for 5 weeks thru phase one. While I get my infusion they take my blood pressure and temperature every 15 minutes, the first couple treatments they also took blood three times throughout the day and also three EKG’s. I begin phase 2 on wednesday, after that I only have to make the trip twice per month. We leave about 6 am and get home about 5pm and 5 hours of that is driving. I hate it, it is exhausting, but it is the only option I had that I felt comfortable with. I’ve done radiation, chemo and an oral chemo targeted therapy. It will be two years in may since my diagnosis. I’ve already outlived the odds I was given. I’m only 45 and not ready to give up. So we trudge on and try and make the best of a bad situation. My husband takes me to most of my appointments. Sometimes we take our travel trailer and spend the night so the next day we can find a nice hiking trail. This trip we are going on up to washington to meet a dog at the inmate prison dog training program. I’m hoping to meet my new best friend and save life.
Ok, enough rambling. I wish you all the best in whatever you choose.
PNW AMTS, I want to hear about the dog! Hope that turns out well for you. Last year after 3months in hospital and rehab center I got a puppy. I was still quite limited mobility wise, so I know some of my friends and family were totally against this, but my husband was agreeing to anything I wanted at that point 
She has been instrumental in helping me, physically and mentally, ever since.
So my appointments on Wed. didn’t go exactly as planned. We are now waiting for an ok from insurance to do another MRI. This will be to try to see if the cervical tumor I had surgery for has come back. If so, they may be able to do another radiation treatment on that. We will be doing radiosurgery on a tumor that’s on my lower back. The other treatment will have to be put off until after the radiation oncologist is through with me. Also, they need a better measurement on my pancreatic mass before I qualify for the clinical trial so that means another ct scan. If I didn’t have cancer already, I’d certainly have it after all these scans! :mad:
My heart and thoughts are with you Toadie’s mom. The pups are always good medicine, I know 
Your family will come around! Hope things pan out in your favor.
Sending best wishes & soft hugs!!
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