LDN and Cancer
Mar. 8, 2007
Protocol for Low-Dose Naltrexone for Cancer
Michael B. Schachter, M.D., CNS, F.A.C.A.M.
Dr. Bernard Bihari of New York City has been using low doses of naltrexone (an opioid-narcotic antagonist) to stimulate immune function in AIDS patients for many years. In 1985, he administered this treatment to an AIDS patient suffering from non-Hodgkin�s lymphoma and was surprised to find that the patient achieved a complete remission. Subsequently, Dr. Bihari followed up on this initial finding and found that a low dose of naltrexone can have a dramatic positive effect on certain other cancers as well.
The treatment probably should be continued for a lifetime, as some patients who obtained complete remission on the treatment, had a recurrence after stopping the naltrexone. Some of these patients were able to obtain a second remission when the medication was restarted.
The treatment seems to work by causing the body to secrete endorphins (metenkephalin and beta-endorphin), which attach to cancers having opiate receptors, shrinking the tumors and inhibiting their growth. Low dose naltrexone may also help cancer patients by up regulating opioid receptors in cancer cells. When metenkephalin and/or beta-endorphins, are attached to cancer cells while they are dividing, it seems to stimulate a process of programmed cell death or apoptosis, thus killing some cancer cells. Low dose naltrexone may also work by so stimulating certain immune system cells that tend to kill cancer cells, including T4 and natural killer cells.
Responses have been seen in cancer patients with a wide variety of cancers. These include: colon cancer, non-Hodgkin�s lymphoma, Hodgkin�s Disease, chronic lymphocytic leukemia, prostate cancer, malignant melanoma, multiple myeloma, neuroblastoma, pancreatic cancer, breast cancer, ovarian cancer, uterine cancer, brain cancer, lung cancer and others.
The protocol is 1.5 to 4.5 mg at bedtime. It must not be a timed-release preparation and should be given at bedtime. Up until recently, Dr. Bihari had routinely used 3 mg, reducing it down to as low as 1.5 mg in the rare patient who experienced a mild sleep disturbance. (Many patients report improved sleeping.) However, recently, he has noted that some patients who did not respond to 3 mg. did respond to 4.5 mg. and has begun to use this dose more frequently. No more than 4.5 mg. must be used. Occasionally, lower doses are necessary. At doses up to 4.5 mg. per day, naltrexone is immune enhancing. At 5 mg. or more daily, it is immune suppressing. The usual, commercial oral preparation of naltrexone is 50 mg; so, the 1.5 to 4.5 mg dose must be made up by a compounding pharmacy. A month�s supply should run about $30. Although there are no known significant side effects to the treatment, in about 1 out of 50 patients, the patient will experience a sleep disturbance. In this case, Dr. Bihari recommends that the pharmacy make up a 100-ml. solution containing naltrexone in distilled water at a concentration of 1 mg/ml. The patient is told to take 1 to 1 � ml. at bedtime�possibly working up to 2 ml. or 2 mg.
According to Bihari, a significant minority of cancer patients obtain a positive response to the treatment. A summary of his results, as well as additional information may be found on his website at http://lowdosenaltrexone.org. He reports improvement as early as within a month and remission frequently occurs within 6 months. Some of his patients have been on the program for more than seven years.
He has recently found that the treatment does not seem to work in prostate cancer patients who have received or are receiving some form of hormone manipulation treatment prior to starting the low dose naltrexone. This includes patients who have received Lupron, Casodex, Eulexin, DES, or other drugs designed to reduce testosterone. In addition, patients who have been treated with PC Spes, the herbal preparation with estrogenic effects, do not seem to respond. I believe this finding may have implications for women who have been treated with hormonal manipulation for breast cancer with drugs such as tamoxifen, aromatase inhibitors, or synthetic progestins, such as Megace. More research is needed to determine if this general principle holds up and if so, the reasons for it. On the other hand, the treatment does seem to work in some patients who have received other forms of conventional treatment, such as radiation and/or chemotherapy. I do not know of any other complementary or alternative cancer (CAM) treatment that interferes with the treatment, although this is a possibility. My guess is that most CAM treatments will turn out to be synergistic with low dose naltrexone.
One contraindication to the use of low dose naltrexone is if the patient is receiving opioid narcotics for pain (painkillers, such as codeine, morphine, Demerol or the Duragesic patch). In such a case, the effect of low dose naltrexone is lost and it may interfere with the pain reducing effects of the opioid narcotic. Also, a patient on opioids may experience withdrawal symptoms if he starts the naltrexone treatment. A patient on opioids must be taken off these drugs by tapering them down, prior to beginning low dose naltrexone. Dr. Bihari uses as a substitute one of the anti-inflammatory drugs Celebrex* (up to 200 mg. BID) or Vioxx* (25 mg. twice daily) and possibly, if necessary, Neurontin* (300 mg. TID). These drugs may be taken daily until the pain is hopefully relieved by the naltrexone. Although, the likelihood of GI bleeding is less with these new COX 2 inhibitors (Celebrex* & Vioxx*), patients should be monitored for possible GI bleeding while taking these drugs.
Obviously, Dr. Bihari�s work needs to be confirmed. However, since it is such a safe and inexpensive treatment, I think any patient who has one of the cancers that have previously responded, should be considered for a trial of low-dose naltrexone. It may also be somewhat helpful for patients whose cancers do not contain opiate receptors because of its immune enhancing effects.
One compounding pharmacy that frequently compounds the low-dose naltrexone is Bigelow�s in New York City (414 6th Avenue--between 8th and 9th Streets: Phone Number: 212-533-2700). A second pharmacy that may be used is Hopewell Pharmacy and Compounding Center (1 West Broad Street, Hopewell, New Jersey 08524, Phone number: 1-800-792-6670; FAX: 1-609-466-8222).
December 6, 2001 * The NSAID Vioxx was taken off the market in 2004. Since the above article was written in 2001, NSAIDS have undergone much scrutiny. Dr. Bihari's protocol may have been changed because of this. Look for a future update of this article, or call the Center for further information.
Breast cancer treatment may fail most women
Researchers say common chemotherapy drugs too risky for many patients
MSNBC.com ANALYSIS By Robert Bazell Chief science and health correspondent Updated: 4:52 p.m. CT June 5, 2007 What if an estimated 100,000 breast cancer patients got drugs that did nothing to combat their cancer, but put them at risk for heart failure and leukemia?
That is the implication of new research that was presented in private session at this week�s meeting of the American Society of Clinical Oncology(ASCO) in Chicago.
The research, from Dr. Dennis Slamon, chief of oncology at the University of California, Los Angeles, suggests that the most widely used chemotherapy drugs may not benefit most women. Although the research hasn't been published or peer-reviewed yet, it is expected to be soon.
The drugs are a common class of treatments called anthracyclines, including doxorubicin, epirubicin, and mitoxantrone. Since their introduction in the 1980s anthracyclines have replaced older chemotherapy drugs in the combination therapies given to women. Administered in the months after surgery and radiation, the chemotherapy is intended to reduce the chances of a life-threatening recurrence of cancer, especially in women at high risk for relapse.
Early on, researchers understood that anthracyclines could cause heart failure in some patients. Recently, evidence has accumulated about the additional risk of leukemia, which can strike years or decades after the treatment.
Evidence for the effectiveness of anthracyclines versus the older drugs remained murky. Then, a 1998 meta-analysis (a study of all the previous studies) found the anthracyclines did a 4 percent better job at preventing recurrence. Despite their side effects, that study elevated the drugs to the standard of care.
Treating many to help few
The UCLA research questions that treatment.
Slamon played a key role in the discovery and development of the hugely successful breast cancer drug Herceptin. Herceptin, which changed the way the disease is treated, specifically targets a gene called Her-2 that is overexpressed in 20 percent to 25 percent of breast cancers (a gene is overexpressed when its effect becomes excessive in the body). Herceptin�s success proved that breast cancer is not one disease, but many, with each benefiting from a tailored treatment.
In this latest study, Slamon looked at a more recently discovered gene called Topoll-2, which is sometimes, but not always, overexpressed along with Her-2. Anthracyclines stop breast cancer because they target Topoll-2.
Slamon examined tissue samples from more than 2,000 women who took part in seven clinical trials. His analysis showed that anthracyclines work only in women who overexpress the Topoll-2 gene. Such women account for 8 percent of breast cancer cases.
The anthracyclines � with all their side effects � have almost no effect in 92 percent of breast cancer cases.
�It seems apparent that we are treating patients who don't need the drug to get at that group who have a huge benefit,� Slamon told me. �And now we need to direct our therapy and target it more specifically.�
Even when other cancer doctors were willing to use anthracyclines only as targeted therapy, they couldn�t. There is no commercial test yet for the Topoll-2 gene, although there likely will be in a few months.
Nevertheless, Johns Hopkins breast cancer specialist Dr. Nancy Davidson calls the findings �an exciting result.�
�It's early; it's provocative. We are waiting to see it go through peer review in the usual fashion,� says Davidson, who is incoming president of ASCO. �But there's a lot of buzz.�
Fran Visco, a cancer survivor and president of the National Breast Cancer Coalition, agrees the work needs to be published and peer-reviewed � very soon.
�This is going to be a sea change in how we treat breast cancer,� she told me. �There is no reason we shouldn't be moving very quickly to publish it and quickly to figure out how we're going to implement it in practice. Women deserve no less.�
Plexus Pink Breast Chek Kit Low Dose Naltrexone Forum - Breast Health Board