TITLE: Managing Menopausal Symptoms in Breast Cancer Survivors

Transcription

1 '.;* * AD GRANT NUMBER: DAMD17-94-J-4507 TITLE: Managing Menpausal Symptms in Breast Cancer Survivrs PRINCIPAL INVESTIGATOR: Patricia A. Ganz, M.D. CONTRACTING ORGANIZATION: University f Califrnia, Ls Angeles Ls Angeles, Califrnia REPORT DATE: Octber 1998 TYPE OF REPORT: PREPARED FOR: Annual Cmmander U.S. Army Medical Research and Materiel Cmmand Frt Detrick, Maryland DISTRIBUTION STATEMENT: Apprved fr public release; distributin unlimited The views, pinins and/r findings cntained in this reprt are thse f the authr(s) and shuld nt be cnstrued as an fficial Department f Army psitin, plicy r decisin unless s designated by ther dcumentatin DHG QUALITY INSPECTED 4

2 REPORT DOCUMENTATION PAGE Frm Apprved OMB N Public reprting burden fr this cllectin f infrmatin is estimated t average 1 hur per respnse, including the time fr reviewing instructins, searching existing data surces, gathering and maintaining the data needed, and cmpleting and reviewing the cllectin f infrmatin. Send cmments regarding this burden estimate r any ther aspect f this cllectin f infrmatin, including suggestins fr reducing this burden, t Washingtn Headquarters Services, Directrate fr Infrmatin Operatins and Reprts, 1215 Jeffersn Davis Highway, Suite 1204, Arlingtn, VA , and t the Office f Management and Budget, Paperwrk Reductin Prject ( ), Washingtn, DC AGENCY USE ONLY (Leave blank) 2. REPORT DATE Octber TITLE AND SUBTITLE Managing Menpausal Symptms in Breast Cancer Survivrs 3. REPORT TYPE AND DATES COVERED Annual (23 Sep Sep 98) 5. FUNDING NUMBERS DAMD17-94-J AUTHOR(S) Patricia A. Ganz, M.D. 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) university f Califrnia, Ls Angeles Ls Angeles, CA PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) Cmmander U.S. Army Medical Research and Materiel Cmmand Frt Detrick, Frederick, Maryland SPONSORING/MONITORING AGENCY REPORT NUMBER 11. SUPPLEMENTARY NOTES 12a. DISTRIBUTION / AVAILABILITY STATEMENT 12b. DISTRIBUTION CODE Apprved fr public release; distributin unlimited i3. ABSYRÄÖT /Maximum SÖÖ Symptms f estrgen deprivatin cmmnly ccur in breast cancer survivrs as a result f natural menpause, r menpause that is precipitated prematurely by chemtherapy r anti-estrgen therapy with tamxifen. In this research prgram, we are evaluating the rle f a cmprehensive menpausal assessment (CMA) and interventin prgram fr management f menpausal symptms in breast cancer survivrs. During the past funding year, we have cntinued recruiting wmen and randmizing them int the experimental r usual-care grups. The experimental grup receives immediate assessment and interventin fr their symptms, while the usual-care grup receives n menpause related interventin during a fur mnth perid f bservatin. Systematic assessment f each breast cancer survivr assigned t the interventin grup permits treatment f multiple symptms simultaneusly with a variety f nn-estrgen pharmaclgic, educatinal and behaviral interventins. We will be assessing the impact f the interventin n quality f life and the reslutin f specific menpausal symptms. 14. SUBJECT TERMS 15. NUMBER OF PAGES Breast Cancer PRICE CODE 17. SECURITY CLASSIFICATION OF REPORT Unclassified 18. SECURITY CLASSIFICATION OF THIS PAGE 19. SECURITY CLASSIFICATION OF ABSTRACT Unclassified 20. LIMITATION OF ABSTRACT Unlimited Unclassified NSN Standard Frm 298 (Rev. 2-89) Prescribed by ANSI Std. Z39-18

3 FOREWORD Opinins, interpretatins, cnclusins and recmmendatins are thse f the authr and are nt necessarily endrsed by the D.S. Army. _v/. Where cpyrighted material is quted, permissin has been btained t use such material. _^ Where material frm dcuments designated fr limited distributin is Qtuted, permissin has been btained t use the material. v Citatins f cmmercial rganizatins and trade names in this reprt d nt cnstitute an fficial Department f Army endrsement r apprval f the prducts r services f these rganizatins. _fcllll In cnducting research using animals, the investigatr(s) adhered t the "Guide fr the Care and Use f Labratry Animals," prepared by the Cmmittee n Care and use f Labratry Animals f the Institute f Labratry Resurces, natinal Research Cuncil (NIH Publicatin W , Revised 1385). Fr the prtectin f human subjects, the investigatr(s) adhered t plicies f applicable Federal Law 45 CFR 46. JillLln cnducting research utilizing recmbinant DNA technlgy, the investigatr(s) adhered t current guidelines prmulgated by the Natinal Institutes f Health. MIL In the cnduct f research utilizing recmbinant DNA, the investigatr(s) adhered t the NIH Guidelines fr Research Invlving Recmbinant DNA Mlecules. Ejft_ In the cnduct f research invlving hazardus rganisms, the investigatr(s) adhered t the CDC-NIH Guide fr Bisafety in Micrbilgical and Bimedical Labratries. PI - Signature UDate

4 Fund # DAMD17-94-J-4507 TABLE OF CONTENTS Page Number Frnt Cver SF 298 Frm Frewrd Table f Cntents Intrductin Bdy Cnculsin Appendix References N/A

5 DOD Cntinuatin Reprt Intrductin Funding #DAMD17-94-J-4507 Authr: Patricia A. Ganz, M.D. Breast cancer is the leading cause f cancer in wmen, affecting 1 in 9 wmen in the U.S. Accrding t the mst recent SEER data, wmen with breast cancer have a relative 5-year survival rate f ver 75%. Earlier detectin f breast cancer, as well as imprvements in pst-perative adjuvant therapies, have enhanced the lng term survival fr wmen with this diagnsis. Symptms f estrgen deprivatin cmmnly ccur in breast cancer survivrs as a result f natural menpause, r menpause that is precipitated prematurely by chemtherapy r anti-estrgen therapy with tamxifen. Hrmne replacement therapy, the mst efficacius treatment fr these symptms, is generally cntraindicated in breast cancer survivrs because f its ptential risk f inducing a recurrence f breast cancer. Thus, many breast cancer survivrs endure cnsiderable mrbidity and impaired quality f life (QL) as a result. This research prgram will evaluate the rle f a cmprehensive menpausal assessment (CM A) and interventin prgram fr management f menpausal symptms in breast cancer survivrs. Using a randmized cntrlled design, we will assign symptmatic pstmenpausal breast cancer survivrs t an experimental r usual-care grup. The experimental grup will receive immediate assessment and interventin fr their symptms while the cntrl grup will receive n menpause related interventin during a fur mnth perid f bservatin. Systematic assessment f each breast cancer survivr assigned t the interventin will permit treatment f multiple symptms simultaneusly with a variety f nn-hrmnal pharmaclgic, educatinal and behaviral interventins. The interventin prgram will be prtable, and suitable fr implementatin in a variety f health care settings. We will evaluate the impact f the interventin n QL and the reslutin f specific menpausal symptms. QL will be assessed using standardized measures f health status, md, and sexual functining. Menpausal symptms will be mnitred using self-reprt diary cards. Our primary hypthesis is that the interventin prgram will lead t significant imprvement in QL fr breast cancer survivrs. Prgress reprt n furth year f funding Recruitment and Subject Characteristics During the past year, we cntinued accruing subjects fr the randmized trial. As f Octber 1,1998, a ttal f 197 wmen have been screened ver the telephne. Of thse, 121 (61%) were eligible and interested in participating in the study. Wmen were fund ineligible fr fur main reasns: Inadequate target symptms (38%), Refusal t try ur study medicatins (26%), Medical ineligibility (24%), and Already tried all ur study medicatins (7%). There are n significant differences between the 76 ineligible wmen and the 121 eligible wmen in age, ethnicity, marital status, r tamxifen use. Belw are sme demgraphic statistics frm the tw grups.

6 DOD Cntinuatin Reprt Funding #DAMD17-94-J-4507 Authr: Patricia A. Ganz, M.D. Eligible (N=121) Nt Eligible (N=76) Mean Age % White 88.4% 88.2% % Married 63.6% 71.0% % Currently Taking Tamxifen 53.7% 48.0% The current status f these 108 eligible wmen is as fllws: 68 have cmpleted the study 31 in the experimental grup 37 in the usual care grup 4 are currently in the study (and are expected t finish by 12/98) 21 have drpped ut vluntarily 8 had n time r were t busy 13 had ther reasns 28 were determined t be ineligible fr the study after an in-persn evaluatin 9 had inadequate target symptms 8 had psychiatric difficulties 5 cancelled their appintments and refused t reschedule 3 were medically ineligible 2 refused t take study medicatins 1 had a prblem filling in ur frms The attached Tracking Flw Chart (n page 8) gives mre detail abut hw many wmen have cmpleted each phase f the study. There are currently nly fur wmen wh are still in the study, and recruitment is nw clsed. We anticipate that these wmen will cmplete the study by December, 1998, bringing ur ttal sample size t n=72. Accrding t ur sample size calculatins, this sample size will be great enugh t detect a significant difference between interventins and cntrls n ur tw main utcmes: the MOS vitality scale, and a scale we created by summing seven BCPT items related t ur target symptms. These seven symptms are: ht flashes, difficulty with bladder cntrl when laughing r crying, difficulty with bladder cntrl at ther times, genital itching/irritatin, vaginal dryness, pain with intercurse, and night sweats. Target Symptms in Study Subjects The three target symptms under evaluatin in this study are ht flashes, vaginal dryness and urinary incntinence. Amng the 121 wmen eligible at the telephne screener, 90% reprted severe ht flashes, 41% reprted vaginal dryness and 16% reprted stress incntinence. Frty percent f entering wmen reprted tw r mre f these symptms. During the study, wmen reprt the frequency and severity f their target symptms n baseline and fllw-up questinnaires and als n diary cards, which they fill ut n a daily basis fr the fur weeks preceding their baseline and their fllwup visits. Change in symptms ver time will be described in the tw study grups.

7 DOD Cntinuatin Reprt Wrk in Prgress Funding #DAMD17-94-J-4507 Authr: Patricia A. Ganz, M.D. Three papers frm this study are in varius stages f cmpletin. We are almst finished writing a paper, which was described in last year's cntinuatin reprt, abut the creatin f the atrphy and inflammatin scales frm the Vaginal Exam Frm. We are currently writing a paper n the effect f tamxifen n vaginal symptms and examinatin. Finally, we are als beginning an analysis f the use f alternative therapies, such as herbal remedies, special diet, and psychscial therapies frm the baseline visit data. This year, we als plan t begin the utcme analysis, cmparing the effectiveness f the Cmprehensive Menpausal Assessment (CMA). Cnclusin As f December, 1998, we will be cmpletely finished cllecting data, and plan t spend the next year cncentrating n data analysis and writing papers. We plan t reprt n several tpics, including use f alternative therapies, effectiveness f the CMA, and evaluatin f the hrmnal data. This study is rich in data, and is sure t prduce sme interesting results. Althugh this was the final year f funding, we have applied fr and received a n-cst extensin in rder t cmplete ur analyses. We will reprt ur final findings next year.

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