Results of A Modified COC Protocol

[PhilipSZacarias]

First, some background history. I was diagnosed in January 2016 with Gleason 9 and metastatic PCa. I have undergone ADT, chemotherapy and SBRT to the prostate and have augmented the standard of care with a regimen that appears to have suppressed my PSA until mid 2019 when it started to rise. The nadir was 0.085 ng/ml and the rate of rise since mid year has been increasing each month (3rd order polynomial).

For the last 2 years I have been reviewing research papers on the repurposing of drugs and drug combinations for the treatment of cancer. I have also reviewed Jane McLelland book, “How to Starve Cancer…without Starving Yourself”. On December 4, 2019 I started a regimen modeled on the Care Oncology Protocol but modified with information from previous readings and some of the recommendations in McLelland’s book. The COC website claims that they have been able to double the expected survival time of patients with glioblastoma. The combination of drugs appeared to be rational and supported by literature on the individual components. I was already taking metformin and a statin to slow progression (although I also take the statin to lower my LDL). The major additions to my regimen were fenbendazole (an animal antihelminthic), docycycline (a common antibiotic), a non steroidal anti-inflammatory drug (NSAID, indomethacin) and 6 sessions of intravenous vitamin C (IVC). Other drugs were added to improve the efficacies of the statin and the antihelminthic. This was a self-directed trial to determine whether the COC protocol, or a modified version, could affect the trajectory of the PSA over a two month period.

The Modified COC Protocol consisted of the following repurposed drugs: (Notes in brackets)

1. Metformin: 500 mg x 4 per day, 1000 mg with breakfast and dinner

2. Berberine: 500 mg x 2, 500 mg with breakfast and dinner (1)

3. Tocotrienols: 125 mg x 4, 250 mg with breakfast and dinner; (Unique Tocotrienol) (2)

4. Statin, Crestor (hydrophilic): 20 mg/ day (3)

5. Dipryridamole: 50 mg x 3 day (4)

6. Fenbendazole: 250 mg x 2, with breakfast and dinner (Panacur 10% Suspension) (5)

7. Cimetidine: 200 mg 2-3 hours after dinner (6)

8. Doxycycline: 100 mg in the morning 2-3 hours before breakfast; the dosage was doubled on IVC days (7)

9. Indomethacin: 25 mg x 2 with breakfast and dinner

10. Intravenous vitamin C (IVC): 6 sessions after one month on the modified COC protocol; 25, 50, 75, 75, 75, 75 g ascorbic acid, 2 times per week, 3 weeks total.

Notes:

(1) well tolerated despite taking concomitant metformin; no significant changes in glucose levels and glucose response (using a FreeStyle Continuous Glucose Monitor)

(2) vitamin E has been reported to increase the efficacy of fenbendazole; there is some evidence that T3s may have antineoplastic properties

(3) the COC protocol specifies a lipophilic statin, but there are indications that hydrophilic statins like Crestor may be effective as well

(4) taken to improve efficacy of the statin; also thins blood and affects the immune system (Th1↑)

(5) the COC protocol uses mebendazole, which is the human version; fenbendazole is being used by many on this forum and those that follow Joe Tippens

(6) to increase blood concentration of fenbendazole by inhibiting metabolism by CYP enzymes

(7) discontinued after last IVC session because of increasing intolerance

I obtained the latest blood work results today and have the following to report:

(this was a table - apologies. Date, PSA ng/ml and comments)

November 4, 2019 0.170

December 2, 2019 0.210 Modified COC protocol started after this test

December 30, 2019 0.290 6 sessions of intravenous Vitamin C: 25, 50, 75, 75, 75, 75 g ascorbic acid started after this test (doxycycline continued, tocotrienols discontinued during IVC)

February 3, 2020 0.450 After 2 months of a modified COC Protocol and 6 sessions of IVC

The latest bloodwork results indicate that the PSA is rising at a rate consistent with a 3 order polynomial equation and that interventions described in this post had no effect on the trend. There is still no evidence of progression according to the bone and CT scans. Liver enzymes such as AST and ALT were low and stable so the latest regimen did not cause serious side effects with respect to this organ. ALP and LDH, which are proximate markers for metastastic activity or progression, were low and in the typical range as well. Inflammation markers, such as NLR (neutrophil/lymphocyte ratio), are all in the typical range and below maximums cited in the literature. Technically, I am still considered hormone sensitive although progressing to a resistant phenotype.

It is possible that the poor response to fenbendazole may be due to prior exposure to docetaxel because both drugs disrupt microtublin, although at different sites. An informal survey of posts by people with various cancers, including prostate cancer, who have been taking fenbendazole appeared to indicate that responses may take 1 to 3 months to observe. For the interim period, I will continue with taking fenbendazole, and maybe at an increased dosage (it is well tolerated).

Keeping in mind a large number of drugs were taken simultaneously and not serially, it does not appear that pretreatment with doxycycline and the concurrent exposure to doxycycline followed by intravenous vitamin C had any effect on the PSA trend. The combination may have affected the population of cancer stem cells, which are present in low concentrations, and not the non-stem PCa cells. The benefits of this combination may not be apparent until later in history of the disease. It is also possible that more IVC sessions where required but at $160 a session, I had to limit it to six sessions. It should be noted that IVC can cause short periods of water retention - I gained about 1 lb of water weight after each session which required a couple of days to lose.

I tolerated the COC protocol fairly well for the first 8 weeks, then started developing intolerance (headaches, pressure behind the eyes, nausea, dizziness) due to the doxycycline, although it is reported to be an antibiotic that is well tolerated. After discontinuing doxycycline, I started to return to normal in a couple of days. It should be further noted that doxycycline is associated with a slight weight gain which I attributed to dysbiosis of the microbiome. My gut still has not returned to normal 2 weeks after discontinuing the antibiotic.

My interim conclusions as follows:

1. The COC Protocol appears not to be effective against prostate cancer, or at least not against the particular set clones that I happen to harbor.

2. Fenbendazole at 2 x 250 mg / day may not be sufficient to have a beneficial effect. Higher doses can be tolerated.

3. The combination doxycycline and IVC did not affect the PSA trend. Again, this may be specific to prostate cancer, or to the set of clones that I happen to harbor, or the benefits will present themselves later.

4. Doxycycline at a dosage of 100 mg day (and 200 mg on IVC days) was tolerated for almost two months. Minocycline may be an alterative that can be tested.

I hope the aforementioned is useful. It is my way of giving back to an excellent community of fellow travelers on HealthUnlocked - Malecare.

Apologies for any typos - I checked several times.

Cheers,

Philip

[6357axbz]

Thank-you Phillip

[tango65]

Thanks for sharing.

Best of luck!!

[Haniff]

Hi Philip

Wow thanks a million for sharing your trials with us. Appreciate it.

I did something close except the IVC and some of the stated protocols. Let me state that I did not see any reduction on my PSA and gave up after 6 months.

Now I am on a plant based diet strictly for the last 56 days. I feel lighter not easily bloated. I sleep better as in I get about 3-5 hours of good sleep most nights. And I have been walking 3-5 km on weekdays except for the last one week due to a bout of flu and also for fear of the coronavirus. But will restart tomorrow. And yes I am on supplements daily such as milk thistle, vitamin C, xepamet(Cimetidine), blood thinner, artovarstatin and Vit D. Phew...

My only indulgence, coffee with milk and boiled tea with milk. No sugar.

As expected my PSA is on the rise now hovering at 5.38 and most probably will go on a positive course of Zytiga + prednisone in May. At first I got easily worked up when my PSA kept rising but lately have chosen to ignore it and don’t want to give it its importance. As long as I am feeling great, looking great, loved and full of mirth and still able to chase after and play with my grandchildren, I am very happy and contented.

I am taking it one day at a time, staying very positive although have to be gently reminded by my wonderful wife at times when I get into the doldrums but I remind myself to always enjoy the glory of the moment.

My very best to you.

Haniff

[PhilipSZacarias in reply to Haniff]

Thank you Haniff. I became a grandfather early last year and I have to say that I am very grateful for opportunity to be around children again. My grandson has added to my life immensely. I love playing and feeding my grandson, who is a character in his own right. I work on the PCa project mostly during the gloomy winter months and have an active and happy life the rest of the year. My family is what motivates me to stick around as long as possible. In July another grandchild will come into the world...so I have to work hard on the project and living. Cheers, Phil

[Haniff in reply to PhilipSZacarias]

Hi Philip

Congrats on being a grandfather two times over. I know the joy they bring.

Take good care and spoil yourself silly with the grandchildren.

Haniff

[PhilipSZacarias in reply to Haniff]

👍👍👍

[henukit]

Thanks for posting. I played with similar, pretty much augmented and modified protocol between chemos. Likewise it doesn't seem to do anything. Chemo works well on the other hand. Very well. So does the radiation. Thanks science, scientific method, RCTs, academia, pharma etc.. Yet people will continue to believe a fake science and feed the quacks. I'm not saying COC and whole drug re-purposing isn't worth it. I'm just saying there's much more work from the tube to the clinic. And that's what health science is about.

Btw, you got a good deal on IVC, mine were $260 a pop. Substituted for a few bottles of Cabernet for now, seems more enjoyable. Keep up good work fighting.

[PhilipSZacarias in reply to henukit]

The purpose of the trial was to determine whether it had any efficacy during a period when my PSA was below 2 ng/ml, AST, ALT, LDH, ALP were stable no progression occurring according to bone and CT scans. If the trial worked then it might be useful in delaying castration resistance which was my ultimate goal. If it did not, then I could move on to other therapies. Knowing was better than not for myself and others on this forum as well. Cheers, Phil

[GreenStreet]

Thanks very much for sharing your data in such a helpful way and best wishes to you going forwards.

[ProstateWhisperer]

So, if I'm reading your account correctly, you've only tried the COC protocol for two months? I've read in other places that it takes longer (maybe 6 months) to see results.

[PhilipSZacarias]

Hello Nalaktats, I get the impression that you also take a panoply of drugs and phytochemicals. Cheers, Phil

[PhilipSZacarias]

If the slope, or doubling time, of the PSA had decreased a little then I would have continued. In any case, I developed an intolerance to doxycycline, which made it difficult. Cheers, Phil

[Christopherg]

Thank you so much Philip for

Sharing your extensive research

And for all uptime writing this up

We appreciate you very much

Best to you

Chris

[Claud68]

ncbi.nlm.nih.gov/pmc/articl...

I found this about Benzimidasoles: Fenben seams to be less effective if you take too much. Maybe you can try it again with only 250mg daily???

[PhilipSZacarias in reply to Claud68]

Thank you Claud68 - I didn't have this one. I will review. Cheers, Phil

[Escudilla]

That was wonderful information Philp!

Since 2016? Nice. You make me want rush out and get some SBRT.

The COC protocol is intriguing. With my limited experimentation though, and from what you report, I agree with your #1 conclusion. I don't see enough evidence to warrant my continued investigation.

I don't know that more fenbendazole will work either.

I'm on failing enzalutamide with a 3 month PSADT. I did fenben for 5 months, escalating to 888 mg/day every day (4g of the powder) for the final 2 months before deciding that it had no effect on my PSADT. It does have a cumulative fatigue factor at the higher doses, similar to docetaxel. My eyebrows fell out, which I took as a positive sign. They were the only hair that didn't fall out with docetaxel. Although I expect that the higher dose fenben will produce pharmaceutical effects, it doesn't seem to affect PSADT. Not over these timeframes at these doses anyway.

My regimen included enzalutamide, tamoxifen, ursolic acid, fenbendazole, metformin and doxazosin, with everything but the ENZ added in one month intervals. The complete combo appeared to have no effect for my PSADT. My PSA continued it relentless and steady climb and is at 0.34 on the lastest labs. My latest scan shows the first noted cancer advancement since start of therapy 2 years ago.

I also had some nausea, dizziness, and numb hands, which I attributed to metformin. I dropped metformin in mid-experiment and the issues resolved.

The only positive trend I find in my labs is that the ALK-PHOS started a decline coincidental with tamoxifen last July. The decline has been relatively steady from 116 to 65. Cause and effect? I don't know. These N=1 experiments are tough to evaluate.

Your results, while disappointing, are excellent data and reported well.

Thanks for the good work.

Jens

[PhilipSZacarias in reply to Escudilla]

Thank you Jens for reporting your experience. The loss of eyebrows is interesting and perhaps not unexpected. Docetaxtel and fenbendazole disrupt microtublin but at different sites. Much appreciated. Cheers, Phil

[servopump]

Philip, take a look at the work from Edward Friedman, Ph.D. and prostate cancer.

math.uchicago.edu/~ed/prost...

[PhilipSZacarias in reply to servopump]

Thanks, I will digest and comment.

[servopump in reply to PhilipSZacarias]

to summarize,

• High levels of estradiol cause cell division and mutations in prostate epithelial cells, ultimately leading to cancer.

• High levels of testosterone act to prevent this cell division and can kill the cancer cells.

• The more advanced the prostate cancer, the more likely there are mutations that protect it from testosterone.

• Also, the more advanced the prostate cancer, the more estrogen receptor-alpha present, which makes estradiol more deadly.

my uneducated opinion:

This could be the reason bipolar androgen therapy (BAT) works

[PhilipSZacarias in reply to servopump]

I agree. And it may be the reason that the only response I have achieved to date with anything is when I started DIM (diindolylmethane) in 2017 (@100 mg/day). DIM is an aromatase inhibitor. Unfortunately, its efficacy has decreased starting mid 2019. Doubling the dose to 200 mg/day for a month only slowed the rise in PSA slightly. Cheers, Phil

[pjoshea13]

Hi Phil,

Thanks for the detailed feedback.

Best, -Patrick

[PhilipSZacarias]

I hear you. I have two cupboards dedicated to my paraphernalia much to the consternation of my dear wife. Packing for a 2-3 week trip is a pain. Cheers, Phil

[Claud68]

I posted this interesting study several weeks ago and it seems to confirm what you found:

Overturning dogma

medscape.com/viewarticle/91...

[PhilipSZacarias in reply to Claud68]

Thank you, this could be helpful in convincing my MO to consider bipolar androgen therapy. Cheers, Phil

[Claud68]

Good luck, I cross fingers that it'll help you!

[j-o-h-n]

COC = Congrats On the Children....

Good Luck, Good Health and Good Humor.

j-o-h-n Friday 02/14/2020 7:13 PM EST

[dfridge]

Literally, the same. Started COC protocol on June 22 as well as many of the supplements you are on. I did 2 months of 3 x a week high dose Vit C (75 grams) After two months PSA up from .18 to .48. I talk to the COC doc in two days to detrermine which course. The protocol is well-tolerated however, as of now it doesn't seem to be working. I am gettign PSA every month now, so I will probably continue for 1 more month.

[PhilipSZacarias in reply to dfridge]

I had 18F PSMA scan performed last June and only two lesions were found: a recurrence in the prostate (as expected after SBRT of Gleason 9) and one on the T12 vertebrae. I was polymetastatic (>5 lesions according to bone scans) when diagnosed in early 2016. There is the possibility that the COC protocol for 2 months with concurrent intravenous vitamin C in the last month may have suppressed cancer stem cells (CSC) and the spread of disease. CSC do not express PSA so a change in this population would not have been detected. I have not written off the COC protocol entirely. There is still an ongoing trial in the UK which should report results in the future. Cheers, Phil

[Herman_PSA_OK in reply to dfridge]

It just so happens I wrote about the COC Protocol on another section today. I modified what I wrote to fit in better on this dialog. Hopefully it will be of some use with a different point of view.

I'm familiar with both the COC Protocol and Jane's McLelland's book and give you my bias opinion for what it's worth, your time and maybe save you some money. Like most of you trying to do your research for your advanced stage prostate cancer situation, you try to have an open mind, read the data and perhaps find/meet something and/or individuals that have FIRST HAND personal experience and are willing to share their advanced PCa journey. So, here we go.

I'm in my 6th month of the COC Protocol and the first thought or comment/feedback that comes to my mind at this point in time is, "don't waste your money & time" because it may not deliver swat or enough to warrant the resources since it is not covered by insurance.

They told me it takes at least 1 month and then maybe 3 months of taking the four meds to "start to notice/see any changes." That is varies from person to person. Yeah right? My PSA got much worse and doubling time shorter while on the COC Protocol. Not a good sign and I will most likely end my use of the drugs except use up the Metformin.

I loss 10-lbs. while on the COC Protocol and I attribute it to the Metformin. You can use Berberine and do the same thing for the most part without a script. I was plant-based anyway and my A1C was perfect to begin with with a total cholesterol range of 89 to 118.

So, the only positive thing I can say is I lost the majority of my belly fat and dropped to my lowest total cholesterol of 89 in two months. My wife wants me to regain some weight back and I hope to do so by increasing my muscle and remain as strong as I can strong.

Bottom line, I've read around and you would be hard press to really find enough on the internet forums with positive or supporting details with a COC Protocol PCa impacted success story other than the hype on the companies' web site. Do I sound dissatisfied to you?

Of course, if you are trying to sell something like this and you have case studies on mice, you can skillfully craft the narrative people want to hear. Each type of cancer is different and you can't use the same cookie cutter COC Protocol dogma.

Most individuals I have converse with in private are often dubious about if the COC Protocol was working/worked for them even after more than one year or years of payments of the quarterly $300 (new rate) renewal plus the few hundred dollars in drug cost and delivery. Wow! You dish out say approx. $700 quarterly and you can't give a definitive PCa bio-marker(s) to shoot for or progression to look forward to? Not a good sign and telling of what might be waiting for you as well.

I had such hopes myself and like most of you "I did my research" and then pulled the trigger with my hard earned money only to be let down bigtime with the COC Protocol. I'm a bottom line guy with no time to waste and I expected a measurable PCa bio-marker improvement that I can hang my hat on and feel I did not waste my money and time with blind faith essentially.

I'll tell you at the end why I tried the COC Protocol. So, I did lose weight, disrupted my sleep pattern, got occasional muscle pain, upset stomach once at the beginning and no improvement at all for my advanced PCa. Sounds like something you want to try for yourself? Let me know how you do!

PS - If you are looking to lose some weight as in fat which is important for dealing with PCa. Hands-down, I can vouch that it can do that. PCa? I don't see it at all for advanced PCa.

In closing, doing the chemo and/or with rad while on the COC Protocol is some serious heavy duty stress on your body. I would really pray about that before setting your compass on that route. It just so happens that a friend of mine a few months ago did exactly all those medical treatments and procedures. It was fresh in my mind because my friend is no longer alive today and I miss him and our deep discussions about our PCa journey. It was he who mentioned the COC Protocol to me and I decided to tried it. I will be dumping it on my next renewal.