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Clinical Trials and Vitamin C
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Clinical Trials and Vitamin C

My father was diagnosed with prostate cancer 7 years ago. He's had radiotherapy, hormonal therapy and one chemo. We are in the process of finding out other means of helping him cope with the disease including pain management under hospice care and participation in treatment trials. We have a lot of apprehensions about the trial though, knowing that taking a new not-widely-tested drug could be very risky. Our family is afraid that the side effects would be too much for him to handle as he's gotten older and weaker although he is still ambulatory. To be frank we are afraid that letting him join a trial could make his life more miserable than it is now leaving him wanting to die earlier. We are trying to decide whether we should focus on the management of his pain or finding a good chance to cure him. What is your opinion on this? Also, would it be ok for my father to take megadoses of Vit C?  I am aware that there is an ongoing clinical trial for a new combo drug (vit C & K3) for prostate CA.  The daily intake is supposed to be 5000mg of vit C & 50mg of vit K3. Since ascorbic acid may be bad for the stomach, a buffered version of C (sodium ascorabate) would be better when taken in megadoses. I know this for a fact since I'm taking this C at 2000mg-3000mg per day and it has cured most of my health complaints. But I don't have cancer so how about my father's case? Do you think it's safe and not contraindicated with the rest of his regular CA drugs because it's only a vitamin? Thank you very much for your opinion!
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Avatar_dr_f_tn
Hi,`
How old is your father?

Vitamin C is known to be a prostate irritant under normal conditions. However, effects of vitamin C on him in his present state may not be beneficial.

Studies of prostate cancer have identified that prostate tumors consume more vitamin C.

Additionally, the additional dose of vitamin C especially in large amounts can interfere and reduce the efficacy of radiotherapy.

So, do not start any vitamin supplementation without discussing it with your dad's oncologist.

If he has had metastasis of the primary tumor or a recurrence after treatment, it would be better to focus on  pain management.

A clinical trial would be an option if you are ready for moderate or no response as if it is a blinded and controlled trial, it is possible that your dad may also be among the arm of the trial receiving the control treatment instead of the trial treatment. Also, you can opt out of the trial whenever you feel that he is unable to carry on with the treatment.

Do keep us posted on your doubts.
Regards,
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Avatar_n_tn
Thank you very much for your reply! You have given helpful information to our family.

My father is 79 years old. After 7 years, his CA already metastasized to his bones but his vital organs are ok. There are more days when he seems like he can no longer hold on while some days he looks much better with some pain that is a lot less than the usual. He’s neither in chemotherapy or radiotherapy right now. His hormonal therapy was discontinued recently as well.

Fact is we did ask at least one of his many doctors about him taking vitamin C. We were told that any vitamin supplement is ok and safe and we’re free to let my father take it but he doesn’t recommend it or wants to prescribe it as part of his treatment. We only asked about vitamin C in particular because of a current study I read, the Apatone (combo vitamins C + K3) which you may have read about too. After inquiry, I was told plans are in for Phase III but they’re not recruiting yet. So far the results are very promising as far as treatment of prostate CA is concerned. We also considered another study, the Abiraterone, which is also a very promising chemo drug.  Although they’re recruiting for phase III and we have contacted them for this, the location of the study is too far from where we are so it didn’t push through. Recently my father was recommended by his oncologist to another study, a comparison of a new chemo drug to a standard chemo drug. We thought of him joining and backing out when he feels he can’t carry on with it but we’re aware that the side effects of a new chemo drug is unpredictable and, as in any standard chemo drug, may linger on even after the initial dose. I’ve also read that drugs on trial also carry the risk of being fatal and we don’t feel right about this (enlighten me on this one though).

We asked my father whether he wants to be under hospice care or go on with the treatment but he left it to our family to decide. We’re leaning more on pain management because we can’t stand seeing him suffer, but at the same time we feel guilty not giving him the hope of cure while there is one and which he is aware of. And a hope for cure means a good chance to have him with us longer. This is a tough decision for our family to make and a professional advice from caring physicians like you would be most helpful. Again, thank you very much

Best regards.
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Avatar_dr_f_tn
Hi,
I commend you and your family on the rational approach you have taken in helping your father deal with the cancer. It is very easy to lose perspective under the emotional strain that evolves under the circumstances.

With metastases to the bone, the prognosis is not very encouraging. However, most of the treatment can be focused toward pain management so as to improve quality of life.

The link pasted below provides certain recommendations for vitamin-C use in prostate cancer.
www.csmc.edu/3430.html

Clinical trials have different phases: phase 0 for a single subthreshold dose to evaluate action of the drug in the body, phase I for safety studies to evaluate the safe dose of the drug, phase II for efficacy studies, usually in comparison with current standard treatment, phase III for evaluating efficacy in larger populations, and phase IV/ post-marketing surveillance studies to check for long-term effects of the drug.
The initial 2 phases of the trial are the ones that have chances of toxicity and fatality, but these are usually carried out in healthy, male volunteers. Phase II checks for efficacy, and in the case of Apatone, has already been completed. Phase III is yet to begin and enrolment will be based on specific inclusion and exclusion criteria. This can include the type of treatment the subject has received, the stage of tumor, spread, etc.

All stages of the clinical trial carry some amount of risk of adverse and serious adverse reactions (including life-threatening conditions) and have standard protocol specified for their management. This risk diminishes drastically after phase I and diminishes with each consecutive phase. If it is a phase II or III study you can consider letting your father join the study, with the reservation that he can leave the study if he finds it difficult to continue the treatment regimen or schedule. Do read the INFORMED CONSENT DOCUMENT as this lists the side effects of the drug and the reactions that have occurred in the previous phases. If it lists any life-threatening complications, your father can decide not to go ahead with the study. Ample time will be provided to think about and discuss options of joining the study and you can seek clarifications for your doubts.

Currently, Apatone has been provided orphan-drug status by the FDA and is approved for the treatment of bladder cancer with bone metastasis, but not for prostate cancer.

At your father's age, you will have to decide whether he has lived a full life and whether he needs prolonged or painful intervention that may compromise his quality of life. Guilt is something that should not enter the picture here. Knowing how much to do and when to let go is as important as all that you have done for him in the past.

regards,
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Avatar_n_tn
Thank you very much for that quick reply! That's a very enlightening message you gave us. We really appreciate your taking the time to explain things to our family. We shall surely discuss our options for my father with your comments in hand. We’re also in the process of trying to relay our fears and doubts with his oncologist and hopefully, after presenting our several questions in mind, we can come up with a favorable agreement.

I must say that there are so many conflicting reports about vitamin C and cancer - and even any other disease for this matter - that it makes me wonder how come the medical community can't agree, at least in part, on something that has been repeatedly studied and discussed since Dr. Linus Pauling in the 70s? There must have been a factual conclusion somewhere, sometime after all these years.

In a recent web publication (HealthDay Reporter - Aug 5, 2008) it reads: “New research with mice suggests that intravenous doses of vitamin C could one day reduce the size of cancerous tumors in people.” This and similar recent studies may sound new to some readers, but Drs Pauling & Cameron have said this over 30 years ago and I'd say back then (and maybe until now) it barely caused a ruffle in the medical community considering that it could be a possible breakthrough for the much dreaded disease. In the Cancer Monthly published on Dec. 10, 2007 they gave a comment that sounds more conclusive to me: "But, maybe the issue all along was not the fact that vitamin C is an effective and non-toxic therapy, but rather that drug companies cannot make millions of dollars from it because as a vitamin it is difficult to patent. If this is the case, it would be another example of how economics not medicine decides what therapies are made available for cancer". As a medical practitioner, what is your opinion on this?

Also, I've mentioned before that I've been taking vit C in its buffered form (oral sodium ascorbate) and it works great for me (especially for me), my son and my husband. It’s tummy friendly and has cured a lot of the health problems that have been bothering us for years. Because of this  (and after all the stuff I've read about vit C) I'm very much tempted to let my father try sodium ascorbate as a therapy, not to cure him -- although I'm very much hoping and praying for that -- but at least to let him have a better quality of life. Since he's no longer on chemo (at least until we decide on letting him join the treatment trial) hopefully this will not contradict with anything he's taking at the moment which are all pain killers and symptom relievers. But then I read the link you gave me at Cedars-Sinai and it says that the RDA is only 60mg which is way behind what megadose advocates suggest (from 3000mg to over 10g ). This and similar articles make me think more than twice about suggesting vit C therapy (sodium ascorbate in particular because it’s the one I’m taking and have tested to be good) to other family members. For us who are not stricken with cancer but are not in perfect health either, what would you suggest as far as intake of sodium ascorbate is concerned?

Looking forward to your comments!
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Avatar_n_tn
There is a blog about using Vitamin C in IV form for cancer: http://www.beating-cancer-gently.com/nl98.html
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Avatar_n_tn
I haven't been able to check this site for a while since I've been busy with some stuff. Thank you very much for that referral. I'll surely be checking that out.
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