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
REFERENCES
1. Mock V, Atkinson A, Barsevick A, et al. NCCN Practice Guidelines for Cancer-Related Fatigue. Oncology (Williston Park) 2000;14:151–161. [PubMed]
2. Mock V. Fatigue management: Evidence and guidelines for practice. Cancer. 2001;92:1699–1707. [PubMed]
3. Fulton C, Knowles G. Cancer fatigue. Eur J Cancer Care (Engl) 2000;9:167–171. [PubMed]
4. Gutstein HB. The biologic basis of fatigue. Cancer. 2001;92:1678–1683. [PubMed]
5. Vogelzang NJ, Breitbart W, Cella D, et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: Results of a tripart assessment survey—The Fatigue Coalition. Semin Hematol. 1997;34:4–12. [PubMed]
6. Curt GA, Breitbart W, Cella D, et al. Impact of cancer-related fatigue on the lives of patients: New findings from the Fatigue Coalition. Oncologist. 2000;5:353–360. [PubMed]
7. Chow E, Fung K, Panzarella T, et al. A predictive model for survival in metastatic cancer patients attending an outpatient palliative radiotherapy clinic. Int J Radiat Oncol Biol Phys. 2002;53:1291–1302. [PubMed]
8. Baker F, Denniston M, Smith T, et al. Adult cancer survivors: How are they faring? Cancer. 2005;104:2565–2576. [PubMed]
9. Bower JE, Ganz PA, Desmond KA, et al. Fatigue in long-term breast carcinoma survivors: A longitudinal investigation. Cancer. 2006;106:751–758. [PubMed]
10. Bower JE, Ganz PA, Desmond KA, et al. Fatigue in breast cancer survivors: Occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000;18:743–753. [PubMed]
11. Mitchell SA, Berger AM. Cancer-related fatigue: The evidence base for assessment and management. Cancer J. 2006;12:374–387. [PubMed]
12. Mitchell SA, Beck SL, Hood LE, et al. Putting evidence into practice: Evidence-based interventions for fatigue during and following cancer and its treatment. Clin J Oncol Nurs. 2007;11:99–113. [PubMed]
13. Dimeo FC, Stieglitz RD, Novelli-Fischer U, et al. Effects of physical activity on the fatigue and psychologic status of cancer patients during chemotherapy. Cancer. 1999;85:2273–2277. [PubMed]
14. Mock V, Dow KH, Meares CJ, et al. Effects of exercise on fatigue, physical functioning, and emotional distress during radiation therapy for breast cancer. Oncol Nurs Forum. 1997;24:991–1000. [PubMed]
15. Mock V, Pickett M, Ropka ME, et al. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001;9:119–127. [PubMed]
16. Windsor PM, Nicol KF, Potter J. A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma. Cancer. 2004;101:550–557. [PubMed]
17. Schwartz AL, Mori M, Gao R, et al. Exercise reduces daily fatigue in women with breast cancer receiving chemotherapy. Med Sci Sports Exerc. 2001;33:718–723. [PubMed]
18. Spiegel D, Bloom JR, Yalom I. Group support for patients with metastatic cancer: A randomized outcome study. Arch Gen Psychiatry. 1981;38:527–533. [PubMed]
19. Gaston-Johansson F, Fall-Dickson JM, Nanda J, et al. The effectiveness of the comprehensive coping strategy program on clinical outcomes in breast cancer autologous bone marrow transplantation. Cancer Nurs. 2000;23:277–285. [PubMed]
20. Jacobsen PB, Meade CD, Stein KD, et al. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002;20:2851–2862. [PubMed]
21. Given C, Given B, Rahbar M, et al. Effect of a cognitive behavioral intervention on reducing symptom severity during chemotherapy. J Clin Oncol. 2004;22:507–516. [PubMed]
22. Bower JE. Cancer-related fatigue: Links with inflammation in cancer patients and survivors. Brain Behav Immun. 2007;21:863–871. [PubMed]
23. Challman TD, Lipsky JJ. Methylphenidate: Its pharmacology and uses. Mayo Clin Proc. 2000;75:711–721. [PubMed]
24. Hurd YL, Ungerstedt U. In vivo neurochemical profile of dopamine uptake inhibitors and releasers in rat caudate-putamen. Eur J Pharmacol. 1989;166:251–260. [PubMed]
25. Volkow ND, Wang GJ, Fowler JS, et al. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998;155:1325–1331. [PubMed]
26. Volkow ND, Ding YS, Fowler JS, et al. Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in the human brain. Arch Gen Psychiatry. 1995;52:456–463. [PubMed]
27. Ferris RM, Tang FL. Comparison of the effects of the isomers of amphetamine, methylphenidate and deoxypipradrol on the uptake of I-norepinephrine and dopamine by synaptic vesicles from rat whole brain, striatum and hypothalamus. J Pharmacol Exp Ther. 1979;210:422–428. [PubMed]
28. Gatley SJ, Pan D, Chen R, et al. Affinities of methylphenidate derivatives for dopamine, norepinephrine and serotonin transporters. Life Sci. 1996;58:231–239. [PubMed]
29. Fernandez F, Adams F, Holmes VF, et al. Methylphenidate for depressive disorders in cancer patients: An alternative to standard antidepressants. Psychosomatics. 1987;28:455–461. [PubMed]
30. Homsi J, Nelson KA, Sarhill N, et al. A phase II study of methylphenidate for depression in advanced cancer. Am J Hosp Palliat Care. 2001;18:403–407. [PubMed]
31. Mulhern RK, Khan RB, Kaplan S, et al. Short-term efficacy of methylphenidate: A randomized, double-blind, placebo-controlled trial among survivors of childhood cancer. J Clin Oncol. 2004;22:4795–4803. [PubMed]
32. Thompson SJ, Leigh L, Christensen R, et al. Immediate neurocognitive effects of methylphenidate on learning-impaired survivors of childhood cancer. J Clin Oncol. 2001;19:1802–1808. [PubMed]
33. Wilwerding MB, Loprinzi CL, Mailliard JA, et al. A randomized, crossover evaluation of methylphenidate in cancer patients receiving strong narcotics. Support Care Cancer. 1995;3:135–138. [PubMed]
34. Westberg J, Gobel BH. Methylphenidate use for the management of opioid-induced sedation. Clin J Oncol Nurs. 2004;8:203–205. [PubMed]
35. Reissig JE, Rybarczyk AM. Pharmacologic treatment of opioid-induced sedation in chronic pain. Ann Pharmacother. 2005;39:727–731. [PubMed]
36. Corey PJ, Heck AM, Weathermon RA. Amphetamines to counteract opioid-induced sedation. Ann Pharmacother. 1999;33:1362–1366. [PubMed]
37. Bruera E, Chadwick S, Brenneis C, et al. Methylphenidate associated with narcotics for the treatment of cancer pain. Cancer Treat Rep. 1987;71:67–70. [PubMed]
38. Bruera E, Driver L, Barnes EA, et al. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: A preliminary report. J Clin Oncol. 2003;21:4439–4443. [PubMed]
39. Meyers CA, Weitzner MA, Valentine AD, et al. Methylphenidate therapy improves cognition, mood, and function of brain tumor patients. J Clin Oncol. 1998;16:2522–2527. [PubMed]
40. Schwartz AL, Thompson JA, Masood N. Interferon-induced fatigue in patients with melanoma: A pilot study of exercise and methylphenidate. Oncol Nurs Forum. 2002;29:E85–E90. [PubMed]
41. Sarhill N, Walsh D, Nelson KA, et al. Methylphenidate for fatigue in advanced cancer: A prospective open-label pilot study. Am J Hosp Palliat Care. 2001;18:187–192. [PubMed]
42. Bruera E, Valero V, Driver L, et al. Patient-controlled methylphenidate for cancer fatigue: A double-blind, randomized, placebo-controlled trial. J Clin Oncol. 2006;24:2073–2078. [PubMed]
43. de la Cruz M, Hui D, Parsons HA, et al. Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer. Cancer. 2010;116:766–774. [PMC free article] [PubMed]
44. Lower EE, Fleishman S, Cooper A, et al. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: A randomized clinical trial. J Pain Symptom Manage. 2009;38:650–662. [PubMed]
45. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31:103–115. [PubMed]
46. Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue severity in cancer patients: Use of the Brief Fatigue Inventory. Cancer. 1999;85:1186–1196. [PubMed]
47. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483. [PubMed]
48. Grunberg SM, Groshen S, Steingass S, et al. Comparison of conditional quality of life terminology and visual analogue scale measurements. Qual Life Res. 1996;5:65–72. [PubMed]
49. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990;13:227–236. [PubMed]
50. Hyland ME, Sodergren SC. Development of a new type of global quality of life scale, and comparison of performance and preference for 12 global scales. Qual Life Res. 1996;5:469–480. [PubMed]
51. Buysse DJ, Reynolds CF, 3rd, Monk TH, et al. The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213. [PubMed]
52. Guyatt GH, Osoba D, Wu AW, et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–383. [PubMed]
53. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf/
54. Revicki D, Hays RD, Cella D, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61:102–109. [PubMed]
55. Sloan JA, Cella D, Hays RD. Clinical significance of patient-reported questionnaire data: Another step toward consensus. J Clin Epidemiol. 2005;58:1217–1219. [PubMed]
56. Masand PS, Tesar GE. Use of stimulants in the medically ill. Psychiatr Clin North Am. 1996;19:515–547. [PubMed]
57. http://www.concerta.net/adult/adult-index.html.


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