This monograph was prepared by The Ottawa Integrative Cancer Centre (OICC), in collaboration

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1 CAMEO Cmplementary Medicine Educatin & Outcmes Prgram ThismngraphwaspreparedbyTheOttawaIntegrativeCancerCentre(OICC),incllabratin withthecmplementarymedicineeducatinandoutcmes(cameo)researchprgram.itis partfaseriesfmngraphsbeingdevelpedtshareresultsfareviewftheresearch evidencerelatedtcmmntherapiesandprductsusedwithincancerpatientcare. Thefllwingmngraphisdesignedtsummarizeevidencebasedresearchanddesnt advcatefrragainsttheusefaparticulartherapy.everyeffrtismadetensurethe infrmatinincludedinthismngraphisaccurateatthetimeitispublished. Pleasentethatthismngraphdesntincludeanexhaustivelistfallptentialadverse events;individualsmayexperienceuniquesideeffects.theinfrmatininthismngraph shuldntbeinterpretedasmedicaladvicenrshulditreplacetheadvicefalicensedhealth careprvider.prirtusinganewtherapyrprduct,alwayscnsultalicensedhealthcare prvider. Frthesafeusefnaturalhealthprducts,pleasecnsiderthefllwing: Cnsultalicensedhealthcareprviderprirtusinganaturalhealthprductand makeaplantmnitritseffectivenessandanysideeffects.thisisparticularly imprtantfrpregnantrbreastfeedingwmenandpeplewithseriusmedical cnditins. Thelppreventinteractinswithyurprescribedmedicatin,ensureyur healthcareprviderisawarefanydrugsrnaturalhealthprductsyumay beusing.makesuretnteallnaturalhealthingredientslistedincmpund prducts. Readandfllwallinstructinsntheprductlabel. IfpurchasingnaturalhealthprductsinCanada,lkfrHealthCanadaapprved prducts.lkfrnaturalprductnumber(npn)rhmepathicmedicinenumber (DINHM)nthelabeltidentifylicensedprducts.Avidinternetpharmacies,asthe qualityfprductscanntbeguaranteedandprductsmightntbelicensedfrsale thrughhealthcanada.frmreinfrmatin,visithttp:// mps/prdnatur/abutaprps/cnseng.php Pleasente:Whiletheaimwastdrawfrmthemstextensiveresearch,insme circumstancestheinfrmatinusedwaslimitedbytheselectinandcaliberfavailable researchstudies.fullreferencesareavailableinthecrrespndingfulllengthmngraphs fundnthecameowebsite. Disclaimer TheOICC,incllabratinwiththeCAMEOResearchPrgram,haspreparedthismngraph,aspartfa seriesfmngraphdevelpment,tshareresultsfareviewftheresearchevidencerelatedt cmmntherapiesandprductsusedwithincancerpatientcare.thefllwingmngraphisdesignedt prvideevidencebasedresearchandneitheradvcatesfrragainsttheusefaparticulartherapy. Everyeffrtismadetensuretheinfrmatinincludedinthismngraphisaccurateatthetimeitis published.prirtusinganewtherapyrprduct,alwayscnsultalicensedhealthcareprvider.the infrmatininthismngraphshuldntbeinterpretedasmedicaladvicenrshulditreplacethe advicefaqualifiedhealthcareprvider. CAMEO&OICC2013

2 CAMEO Cmplementary Medicine Educatin & Outcmes Prgram VITAMIN D Prper Name Vitamin D; vitamin D3 (chlecalciferl); vitamin D2 (ergcalciferl) Cmmn Name Vitamin D; the sunshine vitamin Cmmn Uses in Cancer Care Preventin f cancer develpment and recurrence; Optimizatin f vitamin D status may imprve cancer treatment utcmes and survival; Treatment f musculskeletal pain, especially secndary t armatase inhibitrs; Preventin f bne density lss secndary t hrmnal therapies. Rute f Administratin Oral Mechanism f Actin The actins f vitamin D are quite cmplex, as the vitamin D receptr is present n mst types f cells in the bdy. Vitamin D has anti-prliferative effects, immune mdulating effects, and assists with calcium absrptin and depsitin in relatin t bne health. Clinical Evidence related t Preventin f Breast Cancer One f tw large RCTs fund that supplementatin with 1100 IU vitamin D mg calcium daily ver 4 years reduced risk f all cancer by 60%. Effects n individual cancer types were nt evaluable (1). The secnd RCT, the Wmen s Health Initiative fund nt significant effect frm supplementatin f a very small dse f vitamin D, 400 IU per day, which may be related t the lw dsage used (2). Six ut f six case cntrl studies assessing circulating 25(OH)D reprted inverse assciatins between 25(OH)D and risk f breast cancer. There was a threshld fr prtective effects at 60 nml/l r greater cmpared t <30 nml/l (24 vs 12.5 ng/ml), as well as fr 75 t 150 nml/l cmpared t 50 nml/l (30 t 60 vs 20 ng/ml)(3-8). Only 2 chrt studies assessed 25(OH)D and risk f breast cancer; bth shwed n impact n risk n develpment f breast cancer (9, 10). Clinical Evidence related t Preventin f Breast Cancer Recurrence r Survival All three chrt studies assessing 25(OH)D and risk f recurrence r distant disease fund aninverse assciatin, meaning that vitamin D appeared t be prtective against recurrence and distant disease(11-13). This effect was evident at vitamin D levels f 75 nml/l r higher (30 ng/ml). Lw vitamin D levels have als been assciated with increasing nctype scre (14), and cytlgical atypia n screening bipsies and increased Ki-67 expressin (15). Page 1

3 Clinical Evidence related t Effectiveness fr Armatase Inhibitr Induced Arthralgia One chrt study fund that supplementatin achieving levels f 25(OH)D >100 nml/l (40 ng/ml) reduced musculskeletal symptms assciated with armatase inhibitr therapy (16). A secnd study fund similar assciatins with reduced musculskeletal pain (17). Tw uncntrlled trials and ne RCT als demnstrated that vitamin D supplementatin f 10,000 per day ver a perid f 4 mnths (18), r 50,000 IU per week fr up t 16 weeks (19, 20) resulted in significant imprvements in pain secndary t armatase inhibitrs. In additin, these dsing schedules were reprted t be safe, with the nly adverse events reprted being hypercalcuria r hypercalcemia seen nly in tw patients wh were diagnsed with primary hyperparathyridism (18). Clinical Evidence related t Estrgenic Effects Since vitamin D acts thrugh the vitamin D receptr (VDR) present n cells thrughut the bdy, it des nt exert estrgenic effects thrugh interactins with the estrgen receptr (ER). Adverse Events andside Effects High dse vitamin D appears t have a relatively gd safety prfile. Human trials have reprted very few incidents f hypercalcemia r hypercalcuria(n=3) in several studies utilizing dsages f up t 10,000 IU per day r 50,000 IU per week ver a perid f 3-4 mnths (18-22). High dse vitamin D dsing shuld be accmpanied by regular mnitring f 25(OH)D, calcium, and parathyrid hrmne levels. Interactins with ther Therapies, including Drugs and Natural Health Prducts There is little data n ptential interactins between vitamin D and chemtherapy drugs. Vitamin D may decrease arthralgia induced by armatase inhibitrs. Cautins and Cntraindicatins High dse vitamin D supplementatin shuld nt be initiated withut prper assessment and mnitring. Vitamin D has been shwn t be safe at dsages up t 4000 IU per day during pregnancy (23) and up t 6400 IU during lactatin (24). Dsing, frequency and length f treatment Dsing shuld be discussed with yur healthcare prvider. Althugh high dse vitamin D dsing schedules have been shwn t be quite safe, dses greater than IU per day shuld nt be undertaken withut an assessment f current vitamin D status, bld 25(OH)D. Vitamin D shuld be dsed t achieve levels greater than 75nml/L, and up t 150 nml/l. Accrding t a dsing schedule develped by Alia (amng nn-cancer patients), vitamin D supplementatin based n baseline 25(OH)D levels was able t achieve levels >75 nml/l (30 ng/ml) after 18 weeks in all patients. The strategy was such that patients with levels nml/l (32 ng/ml) were given a dse f 2000 IU per day; while thse with levels <50 nml/l (20 ng/ml) were given 4000 IU per day; and dsages were adjusted at 8 weeks based n 25(OH)D levels at that time. (Alia) It is pssible that higher dsage may be superir fr cancer patients, particularly thse underging treatment Page 2 CAMEO & OICC 2013

4 with armatase inhibitrs, hwever this shuld be determined with the assistance f a healthcare prvider. Disclaimer The OICC, in cllabratin with the CAMEO Research Prgram, has prepared this mngraph, as part f a series f mngraph develpment, t share results f a review f the research evidence related t cmmn therapies and prducts used within cancer patient care. The fllwing mngraph is designed t prvide evidence-based research and neither advcates fr r against the use f a particular therapy. Every effrt is made t ensure the infrmatin included in this mngraph is accurate at the time it is published. Prir t using a new therapy r prduct, always cnsult a licensed health care prvider. The infrmatin in this mngraph shuld nt be interpreted as medical advice nr shuld it replace the advice f a qualified health care prvider. References(An asterisk (*) dentes pen-access articles) * 1. Lappe JM, Travers-Gustafsn D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementatin reduces cancer risk: Results f a randmized trial. American Jurnal f Clinical Nutritin Jun;85(6): PubMed PMID: English. * 2. Chlebwski RT, Jhnsn KC, Kperberg C, Pettinger M, Wactawski-Wende J, Rhan T, et al. Calcium plus vitamin D supplementatin and the risk f breast cancer. Jurnal f the Natinal Cancer Institute Nv 19;100(22): PubMed PMID: Pubmed Central PMCID: PMC English. 3. Abbas S, Chang-Claude J, Linseisen J. Plasma 25-hydrxyvitamin D and premenpausal breast cancer risk in a German case-cntrl study. Internatinal Jurnal f Cancer Jan 1;124(1): PubMed PMID: English. * 4. Abbas S, Linseisen J, Slanger T, Krpp S, Mutschelknauss EJ, Flesch-Janys D, et al. Serum 25-hydrxyvitamin D and risk f pst-menpausal breast cancer--results f a large case-cntrl study. Carcingenesis Jan;29(1):93-9. PubMed PMID: English. * 5. Clstn KW, Lwe LC, Mansi JL, Campbell MJ. Vitamin D status and breast cancer risk. Anticancer Research Jul- Aug;26(4A): PubMed PMID: English. * 6. Crew KD, Gammn MD, Steck SE, Hershman DL, Cremers S, Dwrakwski E, et al. Assciatin between plasma 25- hydrxyvitamin D and breast cancer risk. Cancer Prev Res (Phila Pa) Jun;2(6): PubMed PMID: English. 7. Lwe LC, Guy M, Mansi JL, Peckitt C, Bliss J, Wilsn RG, et al. Plasma 25-hydrxy vitamin D cncentratins, vitamin D receptr gentype and breast cancer risk in a UK Caucasian ppulatin. Eurpean Jurnal f Cancer May;41(8): PubMed PMID: English. * 8. Ya S, Suchestn LE, Millen AE, Jhnsn CS, Trump DL, Nesline MK, et al. Pretreatment serum cncentratins f 25- hydrxyvitamin D and breast cancer prgnstic characteristics: A case-cntrl and a case-series study. PLS ONE [Electrnic Resurce]. 2011;6(2). PubMed PMID: English. * 9. Freedman DM, Lker AC, Abnet CC, Linet MS, Graubard BI. Serum 25-hydrxyvitamin D and cancer mrtality in the NHANES III study ( ). Cancer Research Nv;70(21): PubMed PMID: English. * 10. Freedman DM, Chang S-C, Falk RT, Purdue MP, Huang W-Y, McCarty CA, et al. Serum levels f vitamin D metablites and breast cancer risk in the prstate, lung, clrectal, and varian cancer screening trial. Cancer Epidemil Bimarkers Prev Apr;17(4): PubMed PMID: English. * 11. Kim HJ, Lee YM, K BS, Lee JW, Yu JH, Sn BH, et al. Vitamin D deficiency is crrelated with pr utcmes in patients with luminal-type breast cancer. Ann Surg Oncl. 2011;18(7): * 12. Vrieling A, Hein R, Abbas S, Schneeweiss A, Flesch-Janys D, Chang-Claude J. Serum 25-hydrxyvitamin D and pstmenpausal breast cancer survival: A prspective patient chrt study. Breast Cancer Research. 2011;13(4):Article R Gdwin PJ, Ennis M, Pritchard KI, K J, Hd N. Prgnstic effects f 25-hydrxyvitamin D levels in early breast cancer. Jurnal f Clinical Onclgy Aug 10;27(23): PubMed PMID: English. 14. Rickles A, Peppne L, Hustn A, Piazza K, Skinner K. Serum 25-hydrxyvitamin D and prgnstic tumr characteristics in breast cancer patients. Annals f Surgical Onclgy. 2011;18:S Fabian CJ, Kimler BF, Phillips T, Zalles CM. Levels f 25-hydrxy-vitamin D in pre-menpausal wmen at high risk fr develpment f breast cancer. Cancer Research Cnference: 31st Annual San Antni Breast Cancer Sympsium San Antni, TX United States Cnference Start. 2009;69(2 Suppl. S). PubMed PMID: English. Page 3 CAMEO & OICC 2013

5 16. Priet-Alhambra D, Javaid MK, Servitja S, Arden NK, Martinez-Garcia M, Diez-Perez A, et al. Vitamin D threshld t prevent armatase inhibitr-induced arthralgia: a prspective chrt study. Breast Cancer Res Treat Feb;125(3): PubMed PMID: English. * 17. Waltman NL, Ott CD, Twiss JJ, Grss GJ, Lindsey AM. Vitamin D insufficiency and musculskeletal symptms in breast cancer survivrs n armatase inhibitr therapy. Cancer Nursing Mar-Apr;32(2): PubMed PMID: Pubmed Central PMCID: NIHMS PMC English. * 18. Amir E, Simmns CE, Freedman OC, Dranitsaris G, Cle DEC, Vieth R, et al. A phase 2 trial explring the effects f highdse (10,000 IU/day) vitamin D(3) in breast cancer patients with bne metastases. Cancer Jan 15;116(2): PubMed PMID: English. 19. Rastelli AL, Taylr ME, Ga F, Armament-Villareal R, Jamalabadi-Majidi S, Napli N, et al. Vitamin D and armatase inhibitr-induced musculskeletal symptms (AIMSS): A phase II, duble-blind, placeb-cntrlled, randmized trial. Breast Cancer Research and Treatment. 2011;129(1): Khan QJ, Reddy PS, Kimler BF, Sharma P, Baxa SE, O'Dea AP, et al. Effect f vitamin D supplementatin n serum 25- hydrxy vitamin D levels, jint pain, and fatigue in wmen starting adjuvant letrzle treatment fr breast cancer. Breast Cancer Res Treat Jan;119(1): PubMed PMID: English. 21. Campbell J, Hershman D, Maurer M, Kalinsky K, Feldman S. Safety f high-dse vitamin D supplementatin in wmen at high risk fr breast cancer. Jurnal f the Sciety fr Integrative Onclgy Fall;8(4): Peppne LJ, Hustn AJ, Reid ME, Rsier RN, Zakharia Y, Trump DL, et al. The effect f varius vitamin D supplementatin regimens in breast cancer patients. Breast Cancer Res Treat. 2011;127(1): * 23. Hllis BW, Jhnsn D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementatin during pregnancy: duble-blind, randmized clinical trial f safety and effectiveness. J Bne Miner Res Oct;26(10): PubMed PMID: Pubmed Central PMCID: Wagner CL, Hulsey TC, Fanning D, Ebeling M, Hllis BW. High-dse vitamin D3 supplementatin in a chrt f breastfeeding mthers and their infants: a 6-mnth fllw-up pilt study. Breastfeeding medicine : the fficial jurnal f the Academy f Breastfeeding Medicine Summer;1(2): PubMed PMID: Funding fr this prject was prvided by the Canadian Cllege f Naturpathic Medicine Page 4 CAMEO & OICC 2013