What to expect on a trial.

[Nocillo]

Hello all,

I hope you’re all having a good day! I’m researching starting a trial for an estrogen blocker. I speak with the doctor tomorrow and I have a few questions for some of you. I’m in the U.S. Does insurance pay for a trial in general? If the trial is a pill, do you have to go to a facility at a certain time or day to take it, or are you free to take it at home? This trial would be 2 hours from my home, so that doesn’t thrill me. Once the trial is over, are you just turned out on your own to find something else that works? Any other advice you could give me would be welcome.

Thank you all!

[Bettybuckets]

hi Nocillo, How great that you will be getting into a trial. I don’t have a lot of personal info but working in oncology pharma sales I will weigh in from my work experience. if it is oral drugs, they will send you home with them to take on your own. Trial drugs are provided free to participants- insurance would refuse to pay as they aren’t yet FDA approved. They often include all follow up like scans that are required so everyone can get all the standards of the trial design. Sometimes the trial calls for physician’s choice of drug to go against the study drug and you will be followed by the trial doctors plus your own. So that is very good care and a benefit to being in a trial. The big benefit of course is that you will be helping all of us better understand better treatment options in the future…so thank you very much!

[Nocillo in reply to Bettybuckets]

Hi there! I’ve been wondering how you’re doing. Looks like I’ll also be taking Capcitabine, are you still on it? The lobular has re-appeared in my stomach , hence the drug change. Please let me know how you’re doing and thank you for the information!

[Bettybuckets in reply to Nocillo]

Hi Nocilla, great to be in contact! I did very well on the capecitabine for 18 months… no issues but the HFS which was a pain and kept me from walking much… I worked at keeping fit by biking and swimming 400 yards most days… anyway in may I had a small progression so had to start on IV Doxil…I hope you get a long time in this next round.. I miss being in oral meds.. but you do need to try to find the right dose as they start high and will drop when needed. So please don’t suffer too much.

[Nocillo in reply to Bettybuckets]

Thanks for the advice. I do not like suffering at all! Maybe I’ll ask for a lower dose to start. I hope you continue to do well.

[HelenWi in reply to Nocillo]

Hi Beth and Nocillo, I just started capecitabine and I’m putting a teeny amount of voltaren cream on hands and feet twice a day. There was a study that showed it was effective in preventing HFS. I’m taking 3000 mg, 2 weeks on and 1 week off. I wanted to do every other week but oncologist thought to start stronger and see how I tolerate it.

Helen

[Bettybuckets]

they prob won’t just because some people sail thru without the HFS and you might be one of them!

[Tolife_18]

Hi,

Before trying to answer your questions, I want to emphasize that your physician will go through all details of the trial including its design, known side effects of the new drug, frequency of visits. You’ll receive the document called Informed Consent Form where in simple terms all the points are described you’ll need to sign it before any testing confirming you eligibility will start

Typically all tests and dr fees are covered by the pharmaceutical company developing new drug. You’ll never have to pay out of pocket.

You’ll continue receiving the drugs free of charge while you’ll benefit from them. Even if the trial is over.

I’d ask how often you need to go to the hospital given a strenuous commute.

Wishing you the best of luck!

[Nocillo in reply to Tolife_18]

Thank you for your input. It helps a lot.

[13plus in reply to Nocillo]

The above is often true but it all depends on the drugs. The trial I was on, well they were all pre-approved established drugs but not in the combo being trialed. For whatever reason the 2 pill drugs were sponsored by the drug pharma BUT the Faslodex was considered “standard treatment” (as I’d be getting some kind of hormone treatment anyway (their words) so it fell on me to pay for that! They were a tier 2 institution for me, and the same thing happened with the scans. I was pretty upset when I realized all this after I’d started. Only in it for 6 months but cost me about $5 K 😭

So if the contract you sign says “standard treatment will be covered by your insurance” then it really matters that the place you’re going is Tier 1 and covered by your insurance! That way normal co-pays would apply.

If the ENTIRE trial, bloodwork, scans and meds etc is covered by the trial 100% then you’ll be ok . Just be sure you understand it all first before committing .

[Trissh]

Good morning, yes, insurance pays for scans, blood work, visits, but the study drug is given without cost to the patient. That has been my experience. I take home the cycle (my cycles are 28 days) of pills and then go back for blood work and doc approval to continue every 4 weeks. Once you do not tolerate drug(s), or choose to quit, or have progression by Recist criteria, your oncologist will help you decide what treatment is next. --Patty

[SmallMoments]

Hi Nocillo, I just finished a trial that kept me stable for close to 2 years. But as someone mentioned above, the trial doctor and nurses will go over these with you and what is standard for your particular treatment. Some things to keep in mind:

- The first two weeks could be busy since the trial team and sponsor will require baseline measurements before you go on the drug. I was probably going to the hospital about twice or more a week for the first two weeks.

- Usually there is a washout period -- a time where you are not taking any treatment -- before you start the trial drug

- They will give you consent forms so make sure someone on the team goes over this with you.

- Some sponsors (pharma company) will pay for transportation and lodging. Please ask someone on the trial team. They will usually require for you to fill out a form which they will handover to the sponsor to approve

- The amount of time you go back to the hospital depends on the trial but for me, after the first two weeks it was once a month plus scans every 8 weeks. It wasn't too bad I lived close to my hospital.

- Insurance paid for any standard of care treatment (i had fulvestrant shots with my trial drug which Insurance had to cover and scans as well) so keep that in mind if you have co-pay or maximum out of pocket costs.

- In my case, the trial team did not rely on just the usual CT scans. They did a RECIST analysis of how much 2 livers lesions decreased or increased (note this is not a separate test, just a different way of looking at the scans). If I remember correctly, if it was 20% more increase than the last test, then we started talking about getting off the trial. Thankfully, mine decreased quite a bit and I was able to stay for almost two years. But my trial doctor was always in communication with my primary oncologist (via email, phone call) and we were all in conversation about what the next steps were. When I stopped the trial, I started going back to my primary MO for labs and my next treatment (during the trial, I did not go to my primary MO although I could communicate with her if needed)

Hope this helps and all the best with you.