Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Nan Peng, Yi Zhang, Cong Ma, Ming-Wei Yu, Guo-Wang Yang, Qi Fu, Wei-Ru Xu, Xiao-Min Wang

Published in: Trials | Issue 1/2014

Login to get access

Abstract

Background

Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed.

Methods/design

To determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks.

Discussion

The results of this study will provide a new strategy to help relieve AIMSS.

Trial registration

ISCTN: ISRCTN06129599 (assigned 14 August 2013).
Appendix
Available only for authorised users
Literature
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.CrossRef
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.CrossRefPubMed
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.CrossRefPubMed
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: 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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
11.
Niravath P: Aromatase inhibitor-induced arthralgia: a review. Ann Oncol. 2013, 24: 1443-1449. 10.1093/annonc/mdt037.CrossRefPubMed
12.
Burstein HJ: Aromatase inhibitor-associated arthralgia syndrome. Breast. 2007, 16: 223-234. 10.1016/j.breast.2007.01.011.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
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.PubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.PubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRefPubMed
27.
Khanduri S, Dodwell DJ: Aromatase inhibitors and musculoskeletal symptoms. Breast. 2008, 17: 76-79. 10.1016/j.breast.2007.07.034.CrossRefPubMed
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.CrossRefPubMed
Metadata
Title
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
Authors
Nan Peng
Yi Zhang
Cong Ma
Ming-Wei Yu
Guo-Wang Yang
Qi Fu
Wei-Ru Xu
Xiao-Min Wang
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-171

Other articles of this Issue 1/2014

Trials 1/2014 Go to the issue

Study protocol

Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial

Study protocol

Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial

Research

Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities

Study protocol

Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial

Commentary

Commentary on ‘accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimized multi-arm phase I/II trial design’

Study protocol

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial