Cyclophosphamide in ME/CFS Part A:an Open Label Phase-II Study With Six Intravenous Cyclophosphamide

[John Mac]

Should we be discussing how individual patients did on a study that has still 9 months to run?

 

[Mariah]

I think it would be OK since it`s an open study and doubt any of the participants are in this forum @John Mac. And if they are actually presenting data this fall we will soon know more in detail anyways. But I understand your reservation.

 

[greeneagledown]

Should we be discussing how individual patients did on a study that has still 9 months to run?

Seconded. Let's keep that placebo effect as low as possible.

 

[Mariah]

This is a study without a placebo group. They all know they are getting the cyclo, and their last infusion was in january. Any side effects will already have come. Of course I know the placebo effect still comes a little in to play, but a lot less. And I'm pretty sure none of the patients hang around here. But I won't write about any more details.

 

[Sidereal]

In an open label study like this (neither blind nor placebo controlled) there's even more danger of anecdotes online influencing patients' perceptions.

 

[Mariah]

I would disagree strongly, but that`s fine.

 

[deleder2k]

Couldn't someone manage to get a live stream up and running from IACFSME? I am very keen to see Fluge's presentation. If the journal accepts it he will reveal results from the cyclo study.

 

[Kati]

The main limiting factors from Cyclo are drop in blood counts - sometimes it is necessary to delay the next dose or decrease the dosage and bladder toxicity.

Nausea is definitely a side effect from cyclo, however it can be taken care of by anti-nausea. There are many drugs in the market to counteract this. Oncologists are experts in managing side effects.

Hair loss also occurs with this drug, with total alopecia (going completely bald) with high doses. The dosage used in the trial is not a high dosage, but some will experience partial hair loss.

Bladder toxicity (red blood in urine) is not usually experienced at low dose cyclo. Usually all patients on cyclo are recommended to drink lots on the day of chemo and to go to the bathroom often. With high dosages, patients will receive extra IV saline to prevent bladder toxicity.

It is a drug that needs more surveillance, and I am glad dr Fluge and Mella are being very careful and dilligent by reducing the amount of patients for their severe cohort in order to make it a safe trial. Safety is crucial.

It is interesting to hear the experience of the 2 people who worsened while on the drug. I wonder why, and I am looking forward to the publication.

 

[deleder2k]

Can't one use a chemo cold cap to prevent hair loss? I think they use that at Haukeland.

 

[Kati]

Can't one use a chemo cold cap to prevent hair loss? I think they use that at Haukeland.

http://www.cancer.org/treatment/tre...icalsideeffects/chemotherapyeffects/cold-caps

 

[Mariah]

My friend did use a chemo cap and still had a substantial amount of hair loss. However, she did not loose all of her hair and in pictures I`ve seen from her you can`t really tell that there is much loss at all apart from a thinning of the hair and some spots have less hair than others. Would gladly take a little hair loss to get better though. Hair loss fixes itself.

 

[melihtas]

I don't mind temporary hair loss for a few months at all, if this drug gives my life back.

Here is good amount of info about Cyclo:
General principles of the use of cyclophosphamide in rheumatic and renal disease

 

[Gingergrrl]

Sorry if this is a very stupid question, but is there any hair loss with using RTX or only with Cyclo?

 

[daisybell]

Sorry if this is a very stupid question, but is there any hair loss with using RTX or only with Cyclo?

As far as my knowledge goes, I don't think there should be any hair loss with rituximab- it's only the chemotherapy that affects all cell division that causes hair loss as it breaks at the weak points... so wiping out b-cells shouldn't have any effect. Hoping I'm right!

 

[deleder2k]

No hair loss with Rituximab.

At the dosage their giving with cyclo hair loss does not seem to be a major challenge. Some can lose some hair. They use a chemo freeze cap to minimise the risk of hair loss.

 

[Gingergrrl]

No hair loss with Rituximab.

Thanks and was just curious.

 

[deleder2k]

Only a few days left to IACFSME now. I can't wait. I guess you can't either. Most of this is known, but some new stuff here:

https://worldwide.espacenet.com/pub...T=D&ND=3&date=20160630&DB=EPODOC&locale=en_EP


(Yes, my friends call me mr. Google in real life)

 

[CFS_for_19_years]

Only a few days left to IACFSME now. I can't wait. I guess you can't either. Most of this is known, but some new stuff here:

https://worldwide.espacenet.com/pub...T=D&ND=3&date=20160630&DB=EPODOC&locale=en_EP


(Yes, my friends call me mr. Google in real life)

Next time ask them to call you Professor Google

 

[melihtas]

Out of patients not given previously rituximab treatment, approximately half the patients describe improvement in fatigue symptoms, cognitive function, pain or sleep disturbances.

Only half of the patients improved and only up to a function level 35%. I was planning to start Cyclo next month but now I am not sure the risk reward ratio is reasonable.

 

[deleder2k]

Only half of the patients improved and only up to a function level 35%. I was planning to start Cyclo next month but now I am not sure the risk reward ratio is reasonable.

I am not sure when those stats are from. They did recently extend follow up for 6 months because many patients improvement much later than they expected. I guess we have to wait until IACFSME and wait. Hopefully we'll see some results there. I would not try out cyclo before you know more. They will also probably do a new pilot study on cyclo with a lower dosage because of side effects. A number of patients suffered from an increase in ME symptoms in the study after cyclo infusions.