Integrating Complementary Therapies in the Care of Children with Cancer: Research and Clinical Practice

1. Kara Kelly, M.D. Integrating Complementary Therapies in the Care of Children with Cancer: Research and Clinical Practice

2. What is CAM? • Group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine

3. Complementary: Used together with conventional medicine Alternative: Used in place of conventional medicine Integrative:Combines mainstream medical therapies and CAM therapies for which there is some high quality scientific evidence of safety and efficacy

4. NCCAM Classification • Alternative medical systems(Traditional Chinese Medicine, Ayurveda, homeopathy) • Mind-body interventions(yoga, imagery, meditation, prayer) • Biological based therapies(herbs, high dose vitamins, antioxidants, mushrooms, enzymes ) • Body based therapies(chiropractic or osteopathic manipulation, massage) • Energy therapies(Reiki, therapeutic touch, magnets) nccam.nih.gov

5. Children with Cancer are using CAM % Year of Survey

6. Reasons for CAM Use • "to try everything possible” • to reduce stress of illness • improve quality of life • symptom care management • sometimes for cure Columbia survey: Perceived effectiveness is high- 86% very or somewhat effective for intended purpose

7. How are Patients Using CAM?

8. 73% of children were enrolled on clinical trials for treatment of their malignancy 85% were using some form of CAM: Herbs 25% Nutritional supplements 34% J Pediatr Hematol Oncol 22:412,2000

9. Why the Controversy? • Few clinical trials of safety and efficacy, especially in children • Regulation of herbs and dietary supplements varies world wide, although most are not subject to the same regulations that apply to conventional drugs

10. Adverse Effects • Pharmacologic therapies: • Direct effect • Contamination • Interactions with conventional medications

11. Adverse Effects

12. Contamination of herbs Eur J Pediatr 162:72, 2003

13. Herb-Drug Interactions:Sources of Information HerbalGram 49:2000.

14. Fig. 1. Effect of St. John's wort on the plasma concentration of the active irinotecan metabolite SN-38 over time. JNCI 94:1247,2002

15. Chemotherapy/Herb Interactions

16. Oxidative Stress and Chemotherapy Drugs High Anthracyclines Pt-complexes Alkylating agents Epipodophyllotoxins Camptothecins Purine/Pyrimidine Antimetabolites Low Taxanes Vinca alkaloids

17. Observational Studies: The Effect of Cancer Therapy on Antioxidant Levels (n=31) JCO 22:517, 2004

18. The Effect of Supplementation with Antioxidants in combination with Cancer Therapy on Antioxidant Levels (n=9) JCO 22:517, 2004

19. Immunostimulants • Mistletoe, Asian mushrooms (maitake, reishi, shiitake, coriolus versicolor, PSK), Astralagus • Actions: Increase cytotoxic T-cells or NK cells activity, increase endogenous production of interferon, interleukins, or cytokines Discourage in patients with: Hematologic malignancies, Stem cell transplants

20. Warning signs of Possible Interactions • Tolerance to conventional drug administration that is better or worse than expected: • Unexpected refractoriness to treatment • Unusual toxic effects from treatment Labriola D, Livingston R. Oncology 13:1999

21. Non-pharmacologic Therapies • Chiropractic • cerebrovascular accidents, acute necrosis of holocord astrocytoma, vertebral artery dissection • Acupuncture • cardiac tamponade, epidural abscess formation, HIV infection • overall underlying adverse event rate: 0-1.1 per 10,000 treatments

22. Practitioner Licensure varies from state to state • Chiropractors: every state, Washington DC • Massage therapists: ~25 states • TCM practitioners: ~25 states • Naturopathic physicians: 12 states • Homeopathic physicians: 3 states Dermatologic Therapy 16:77,2003

23. Barriers to Research • Difficulties in conducting studies of complex therapeutic systems • Emotional issues leading to biases in patient recruitment • Lack of standardization of herbs/dietary supplements • Difficulty in determining an adequate placebo • CAM providers may have little incentive for scientific evaluation of CAM therapies

24. Active Randomized Clinical Trials in Pediatric Cancer and CAM • TRAUMEEL S (Homeopathy) for prevention and treatment of Mucositis in SCT (COG) • Electroacupuncture for Chemotherapy induced Delayed Nausea/Vomiting in Pediatric Solid Tumors (NCI) • Silymarin in Maintenance therapy in Children with ALL and Abnormal LFTs (Columbia) • Aromatherapy for Reduction of Anxiety/Nausea during SCT (Columbia) • Massage Therapy and Childhood Cancer (Childrens Minneapolis) • Aromatherapy as an Intervention for Nausea and Vomiting in Children receiving Chemotherapy for Cancer (Childrens Minneapolis)

25. Clinical Services

26. Nausea/Vomiting • Herbs • Ginger, Peppermint, Fennel • Chamomile Compresses • Aromatherapy • Citrus (Bergamont, Mandarin, Citrus Mixtures) • Acupressure • P-6 Point (Acupressure bands)

27. Palliative Care • Alternative medical systems: acupuncture • Mind-body medicine: Meditation, prayer, music therapy • Body-based therapies: Massage • Energy therapies: Reiki, Therapeutic touch

28. Screening for child CAM use: • Do you give your child any herbal or plant products? • Do you give your child any homeopathic products? • Do you use any unconventional/alternative types of care or therapies for your child? • Do you use any special vitamin therapy for your child? • Do you use any unconventional treatments, alternative types of care, or therapies for yourself to stay healthy or to manage a health problem? J Pediatr Health Care 17:58,2003 Questions only identified 24% of parents using CAM

29. www.integrativetherapiesprogram.org

30. The Bottom Line… • Children with cancer are using CAM therapies • Physicians need to inquire about CAM use • Biologically active therapies including herbs and dietary supplements are often used • Adverse effects and especially interactions with conventional drugs are possible • CAM therapies may be especially useful for symptom management