27 februari 2012:

Afgelopen jaren is er veel onderzoek gedaan naar het effect van zogeheten psychostimulerende middelen - zoals bv. Methylfenidaat - Ritalin op bv. moeheid gerelateerd aan kanker. In Wikipedia is een heleboel informatie over deze middelen te vinden. Klik hier voor Nederlandse informatie.

Maar er is ook in 2010 een gerandomiseerde placebo gecontroleerde fase III studie publicatie verschenen naar het effect van deze middelen op kanker. Onderaan staat het abstract van deze studie. Als u hier klikt kunt u het volledige studierapport gratis inzien. De conclusie uit de studie is dat er geen significant verschil is gevonden in het ontstaan van moeheid door kanker door psychostimulerende middelen, maar ze zijn niet goed voor de gezondheid want andere zelf gerapporteerde bijwerkingen waren wel significant in het nadeel van de medicijnengroep zoals slechtere eetlust en nervositeit. Onderaan dit abstract staat dus zoals gezegd het abstract van de fase III studie plus refentielijst  

22 maart 2005: Bron: Lef Extension Daily, d.d. 18 maart 2005

Een kleine maar wel alarmerende studie bij 12 kinderen zou aangeven dat Ritalin gebruik door kinderen, dit wordt heel vaak voorgechreven bij bv. ADHD kinderen, een sterk verhoogd risico geeft op het later krijgen van kanker. Bij alle van de 12 deelnemende en onderzochte kinderen werd al na drie maanden van Ritalin gebruik een ernstige afwijking gevonden van de chromosomen, die weliswaar nog geen kanker zijn maar deze kinderen wel veel kwetsbaarder maken voor het krijgen van kanker. En dat al na drie maanden. Er zijn kinderen die Ritalin jaren achtereen slikken. Goed denk ik om dit in de gaten te houden.

Small Study Links Ritalin, Increased Cancer Risk

The Kansas City Star, Mo.
18 Mar 2005
KANSAS CITY, Mo. - Health experts say the first human study linking Ritalin - the most popular drug used to treat attention-deficit problems - to a higher risk of cancer is raising alarms. But they caution that more and larger studies should be conducted before pediatricians and therapists curtail prescribing Ritalin for the millions of children and adults in the United States who have benefited from its use for more than 50 years. In a study to be published in Cancer Letters, Texas researchers found that after only three months, every one of a dozen children treated with Ritalin had a three-fold increase in chromosome abnormalities associated with increased risks of cancer. "This study doesn't mean that these kids are going to get cancer, but it does mean they are exposed to an additional risk factor, assuming this study holds up," said Marvin Legator, an environmental toxicologist and principal investigator on the study by researchers at the University of Texas Medical Branch at Galveston and M.D. Anderson Cancer Center in Houston. Legator acknowledged this week that the study group is small. But he said it was the first such study involving results in humans. "This should raise a red flag," Legator said. "There's no question we need a bigger study before we take any further major action." The drug is now made by Novartis Pharmaceuticals Corp. In a statement, Novartis repeated the safety record of the drug, which it said has been used for years "with no clinical evidence of a link to the development of cancer in humans. "Novartis continues to stand behind the safety and efficacy of Ritalin, which is an important treatment option for patients with ADHD," the statement said. Ritalin is the most widely prescribed drug for treating attention deficit/hyperactivity disorder. Six million to 10 million Americans, many of them children, take it. The drug is a mild central nervous system stimulant that helps address the neurochemical problems that underlie ADHD. But medical experts said that, until more is known, parents should not be overly frightened of giving the drug to their children. "Cancer is something to be scared about but untreated ADHD is devastating, too," said Kathryn Ellerbeck, a developmental pediatrician at the University of Kansas Medical Center. Ellerbeck said untreated ADHD can lead to other life-threatening problems, including increased risks of accidents, addictive use of alcohol and drugs, and depression. "This is concerning," she said of the new study. "But this is a drug that has been used for many years. And it works." Avner Stern, a Kansas City-area psychologist who treats many children with ADHD, said that despite the troubling study, he would tell parents "to continue using it (Ritalin). Absolutely. But there needs to be more research to look at this carefully." Researchers said they undertook the study because even though methylphenidate - the generic name for a group of drugs that includes Ritalin, Concerta, Metadate-CD and others - has been approved for human use for years, there "are surprisingly few studies" on potential serious side effects. In 1996, a national toxicology report discussed several, two-year animal studies that showed that high levels of methylphenidate caused liver tumors in male and female mice. However, similar studies in rats showed no such tumors. The Food and Drug Administration concluded those studies were not enough to signal that children should be taken off the drug. The drug's then-maker, Ciba-Geigy, told physicians that the national studies at the time suggested Ritalin remained safe and effective. Gregory Kearns, chief of the division of pediatric pharmacology and medical toxicology at Children's Mercy Hospital in Kansas City, agreed that by itself the Texas study is troubling but not conclusive - mainly because it's hard to apply the results broadly. "Millions of children get this medication on a daily basis," Kearns said. "We can't necessarily extrapolate results from those 12 kids to all these other children who use the drug." Kearns said more study is needed because of the difficulty linking chromosome abnormalities and a higher risk of disease. Chromosomes are the bodies within cells that carry genetic information. "There are many other things that have the ability to alter DNA, just like the alterations in the study," he said. "But not everyone who has chromosome alterations gets cancer and that's because there are also genes that repair damage." Sukumar Ethirajan, a Kansas City-area cancer specialist, noted that genetic markers alone don't guarantee someone will get cancer. Ethirajan said environment also plays a major part. The Texas study is being released at a time of concern about other drugs used to treat ADHD. Canada recently pulled Adderall XR, another top-selling ADHD drug, after its manufacturer provided information about 20 patient deaths. Strattera, the first nonstimulant ADHD medication, has been linked by the FDA to liver damage. In the Texas study, researchers drew blood from children diagnosed with ADHD before they began taking Ritalin in order to get a baseline level of chromosomal abnormalities. Three months later, the researchers drew the children's blood and tested it again. All 12 children showed chromosomal breaks that are associated with an increased risk of cancer. Legator said the consistency of the findings, despite the small size of the sample, "was astonishing" to the researchers. Still, he said, "Nobody wants to panic people. "But my own feeling is we have to immediately set up a much larger study to confirm this. Any chemical that causes this kind of chromosomal change is of concern."

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Long-Acting Methylphenidate for Cancer-Related Fatigue: North Central Cancer Treatment Group NCCTG-N05C7 Trial

J Clin Oncol. 2010 Aug 10;28(23):3673-9. Epub 2010 Jul 12.

Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.

Source

Mayo Clinic, Rochester, MN 55905, USA.

Abstract

PURPOSE:

Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities.

PATIENTS AND METHODS:

Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change.

RESULTS:

In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm.

CONCLUSION:

This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

PMID:
20625123
[PubMed - indexed for MEDLINE]
PMCID:
PMC2917307
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