Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: A study protocol for a multicenter, randomized, controlled clinical trial

Trials

Volumn 15, Issue 1, 2014, Pages

  Peng, Nan ^a   Zhang, Yi ^a   Ma, Cong ^a   Yu, Ming Wei ^a   Yang, Guo Wang ^a   Fu, Qi ^a   Xu, Wei Ru ^a   Wang, Xiao Min ^a  

^a BEIJING HOSPITAL OF TRADITIONAL CHINESE MEDICINE AFFILIATED TO CAPITAL MEDICAL UNIVERSITY   (China)

Author keywords

Aromatase inhibitor associated musculoskeletal symptoms; Breast cancer; Traditional Chinese medicine

Indexed keywords

AROMATASE INHIBITOR; CHINESE DRUG; PLACEBO; UNCLASSIFIED DRUG; YI SHEN JIAN GU GRANULE; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; HERBACEOUS AGENT; YI SHEN JIAN GU;

AROMATASE INHIBITOR ASSOCIATED MUSCULOSKELETAL SYMPTOM; ARTICLE; BRIEF PAIN INVENTORY; CHINESE MEDICINE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG GRANULE; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; BREAST NEOPLASMS; CHEMICALLY INDUCED; CHINA; CLINICAL PROTOCOL; CLINICAL TRIAL; FEMALE; METHODOLOGY; MUSCULOSKELETAL DISEASES; PAIN MEASUREMENT; PATHOLOGY; QUESTIONNAIRE; TIME; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; CHINA; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; FEMALE; HUMANS; MUSCULOSKELETAL DISEASES; PAIN MEASUREMENT; QUESTIONNAIRES; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84901262735     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-171     Document Type: Article

References (28)

1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005, 365:1687-1717. Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
2. Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005, 365:60-62.
3. Thurlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005, 353:2747-2757.
4. Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lonning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007, 369:559-570. 10.1016/S0140-6736(07)60200-1, 17307102.
5. Boccardo F, Rubagotti A, Guglielmini P, Fini A, Paladini G, Mesiti M, Rinaldini M, Scali S, Porpiglia M, Benedetto C, Restuccia N, Buzzi F, Franchi R, Massidda B, Distante V, Amadori D, Sismondi P. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer. Updated results of the Italian tamoxifen anastrozole (ITA) trial. Ann Oncol 2006, 17(7):i10-i14.
6. Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, Hilfrich J, Kwasny W, Menzel C, Samonigg H, Seifert M, Gademann G, Kaufmann M, Wolfgang J. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005, 366:455-462. 10.1016/S0140-6736(05)67059-6, 16084253.
7. Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med 2003, 349:1793-1802. 10.1056/NEJMoa032312, 14551341.
8. Jakesz R, Greil R, Gnant M, Schmid M, Kwasny W, Kubista E, Mlineritsch B, Tausch C, Stierer M, Hofbauer F, Renner K, Dadak C, Rucklinger E, Samonigg H. Extended adjuvant therapy with anastrozole among postmenopausal breast cancer patients: results from the randomized Austrian Breast and Colorectal Cancer Study Group Trial 6a. J Natl Cancer Inst 2007, 99:1845-1853. 10.1093/jnci/djm246, 18073378.
9. Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol 2007, 25:3877-3883. 10.1200/JCO.2007.10.7573, 17761973.
10. Henry NL, Giles JT, Ang D, Mohan M, Dadabhoy D, Robarge J, Hayden J, Lemler S, Shahverdi K, Powers P, Li L, Flockhart D, Stearns V, Hayes DF, Storniolo AM, Clauw DJ. Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors. Breast Cancer Res Treat 2008, 111:365-372. 10.1007/s10549-007-9774-6, 3081690, 17922185.
11. Niravath P. Aromatase inhibitor-induced arthralgia: a review. Ann Oncol 2013, 24:1443-1449. 10.1093/annonc/mdt037, 23471104.
12. Burstein HJ. Aromatase inhibitor-associated arthralgia syndrome. Breast 2007, 16:223-234. 10.1016/j.breast.2007.01.011, 17368903.
13. Xu L, Li H, Xu Z, Wang Z, Liu L, Tian J, Sun J, Zhou L, Yao Y, Jiao L, Su W, Guo H, Chen P, Liu J. Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients. BMC Complement Altern Med 2012, 12:112. 10.1186/1472-6882-12-112, 3502343, 22853619.
14. Lin C, Lin X, Yang J. An observation on combined use of chemotherapy and traditional Chinese medicine to relieve cancer pain. J Tradit Chin Med 1996, 16:267-269.
15. Zhou D. Oncology of Traditional Chinese Medicine 2011, Beijing: China Press of Traditional Chinese Medicine.
16. Sun G, Tong Y, Chen W. Basic Theory of Traditional Chinese Medicine 2002, Beijing: China Press of Traditional Chinese Medicine.
17. Muslimani AA, Spiro TP, Chaudhry AA, Taylor HC, Jaiyesimi I, Daw HA. Aromatase inhibitor-related musculoskeletal symptoms: is preventing osteoporosis the key to eliminating these symptoms?. Clin Breast Cancer 2009, 9:34-38. 10.3816/CBC.2009.n.006, 19299238.
18. Rastelli AL, Taylor ME, Gao F, Armamento-Villareal R, Jamalabadi-Majidi S, Napoli N, Ellis MJ. Vitamin D and aromatase inhibitor-induced musculoskeletal symptoms (AIMSS): a phase II, double-blind, placebo-controlled, randomized trial. Breast Cancer Res Treat 2011, 129:107-116. 10.1007/s10549-011-1644-6, 21691817.
19. Crew KD, Capodice JL, Greenlee H, Apollo A, Jacobson JS, Raptis G, Blozie K, Sierra A, Hershman DL. Pilot study of acupuncture for the treatment of joint symptoms related to adjuvant aromatase inhibitor therapy in postmenopausal breast cancer patients. J Cancer Surviv 2007, 1:283-291. 10.1007/s11764-007-0034-x, 18648963.
20. Crew KD, Capodice JL, Greenlee H, Brafman L, Fuentes D, Awad D, Yann TW, Hershman DL. Randomized, blinded, sham-controlled trial of acupuncture for the management of aromatase inhibitor-associated joint symptoms in women with early-stage breast cancer. J Clin Oncol 2010, 28:1154-1160. 10.1200/JCO.2009.23.4708, 20100963.
21. Greenlee H, Crew KD, Shao T, Kranwinkel G, Kalinsky K, Maurer M, Brafman L, Insel B, Tsai WY, Hershman DL. Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer. Support Care Cancer 2012, 21:1077-1087. 3810608, 23111941.
22. Kubo M, Onishi H, Kuroki S, Okido M, Shimada K, Yokohata K, Umeda S, Ogawa T, Tanaka M, Katano M. Short-term and low-dose prednisolone administration reduces aromatase inhibitor-induced arthralgia in patients with breast cancer. Anticancer Res 2012, 32:2331-2336.
23. Zhang Q, Tang D, Zhao H. Immunological therapies can relieve aromatase inhibitor-related joint symptoms in breast cancer survivors. Am J Clin Oncol 2010, 33:557-560. 10.1097/COC.0b013e3181cae782, 20124972.
24. Henry NL, Banerjee M, Wicha M, Van Poznak C, Smerage JB, Schott AF, Griggs JJ, Hayes DF. Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms. Cancer 2011, 117:5469-5475. 10.1002/cncr.26230, 21692065.
25. Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther 2012, 11:313-320. 10.1177/1534735411413270, 21733988.
26. Din OS, Dodwell D, Wakefield RJ, Coleman RE. Aromatase inhibitor-induced arthralgia in early breast cancer: what do we know and how can we find out more?. Breast Cancer Res Treat 2010, 120:525-538. 10.1007/s10549-010-0757-7, 20157776.
27. Khanduri S, Dodwell DJ. Aromatase inhibitors and musculoskeletal symptoms. Breast 2008, 17:76-79. 10.1016/j.breast.2007.07.034, 17822901.
28. Mieog JS, Morden JP, Bliss JM, Coombes RC, van de Velde CJ. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study. Lancet Oncol 2012, 13:420-432. 10.1016/S1470-2045(11)70328-X, 22265698.