Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck

被引：50

作者：

Allison, Ron R. ^{[1
]}

Ambrad, Aaron A. ^{[2
]}

Arshoun, Youssef ^{[3
]}

Carmel, Richard J. ^{[4
]}

Ciuba, Doug F. ^{[5
]}

Feldman, Elizabeth ^{[6
]}

Finkelstein, Steven E. ^{[7
]}

Gandhavadi, Ranjini ^{[8
]}

Heron, Dwight E. ^{[9
]}

Lane, Steven C. ^{[10
]}

Longo, John M. ^{[11
]}

Meakin, Charles ^{[12
]}

Papadopoulos, Dimitrios ^{[13
]}

Pruitt, David E. ^{[14
]}

Steinbrenner, Lynn M. ^{[15
]}

Taylor, Michael A. ^{[16
]}

Wisbeck, William M. ^{[17
]}

Yuh, Grace E. ^{[18
]}

Nowotnik, David P. ^{[19
]}

Sonis, Stephen T. ^{[20
]}

机构：

[1] 21st Century Oncol Carolina Radiat Med, Greenville, NC USA

[2] Ironwood Canc & Res Ctr, Mesa, AZ USA

[3] Allegheny Gen Hosp, Pittsburgh, PA 15212 USA

[4] John Muir Hlth Med Ctr, Concord, CA USA

[5] John B Amos Canc Ctr, Columbus, GA USA

[6] MD Anderson Canc Ctr, Orlando, FL USA

[7] 21st Century Oncol Translat Res Consortium TRC, Scottsdale, AZ USA

[8] Columbia St Marys Hosp, Milwaukee, WI USA

[9] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA

[10] Signature Healthcare Brockton Hosp, Brockton, MA USA

[11] Missouri Valley Canc Consortium, Omaha, NE USA

[12] CaroMont Hlth Comprehens Canc Ctr, Gastonia, NC USA

[13] Vassar Bros Med Ctr, Poughkeepsie, NY USA

[14] St Josephs Mercy Canc Ctr, Hot Springs, AR USA

[15] VA Western New York Hlth Syst, Buffalo, NY USA

[16] Peace Hlth St Joseph Canc Ctr, Bellingham, WA USA

[17] Providence Reg Med Ctr, Everett, WA USA

[18] Enloe Med Ctr, Chico, CA USA

[19] Access Pharmaceut Inc, Dallas, TX 75219 USA

[20] Clin Assistance Programs LLC, Framingham, MA USA

来源：

CANCER | 2014年 / 120卷 / 09期

关键词：

head and neck cancer; mucoadhesive gel; chemoradiation; mucositis; REPORTED OUTCOMES; QUESTIONNAIRE; IMPACT;

D O I：

10.1002/cncr.28553

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

BACKGROUND The objective of this trial was to determine how a mucoadhesive hydrogel (MuGard), a marketed medical device, would fare when tested with the strictness of a conventional multi-institutional, double-blind, randomized, placebo-controlled study format. METHODS A total of 120 subjects planned to receive chemoradiation therapy (CRT) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse (SC) during CRT. Subjects completed the validated Oral Mucositis Daily Questionnaire. Weight, opiate use, and World Health Organization (WHO) oral mucositis (OM) scores were recorded. Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis. RESULTS Of 120 subjects enrolled, 78 (SC, N = 41; MuGard, N = 37) were eligible for efficacy analysis. Both cohorts were similar in demographics, baseline characteristics, primary tumor type, and planned CRT regimen. MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness (P = .034) and WHO scores on the last day of radiation therapy (P = .038). MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration, and OM scores (WHO criteria) at CRT week 4. Rinse compliance was identical between cohorts. No significant adverse events were reported, and the adverse event incidence was similar between cohorts. CONCLUSIONS Testing MuGard, a rinse marketed as a device, in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms, delaying OM progression, and its safety and tolerability. Cancer 2014;120:1433-1440. (c) 2014 Access Pharmaceuticals, Inc. Cancer published by Wiley Periodicals. Inc. on behalf of American Cancer Society.

引用

页码：1433 / 1440

页数：8

共 20 条

[1]

Patient-Reported Outcomes in Supportive Care [J].

Bateman, Emma ;

Keefe, Dorothy .

SEMINARS IN ONCOLOGY, 2011, 38 (03) :358-361

[2]

Baud CM, 2006, MASCC ISOO INT S TOR

[3]

Chan Alexandre, 2005, J Oncol Pharm Pract, V11, P139, DOI 10.1191/1078155205jp166oa

[4]

Daly CF, 2013, ONCOL NURS ADVISOR

[5]

Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis [J].

Dodd, MJ ;

Dibble, SL ;

Miaskowski, C ;

MacPhail, L ;

Greenspan, D ;

Paul, SM ;

Shiba, G ;

Larson, P .

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY AND ENDODONTOLOGY, 2000, 90 (01) :39-47

[6]

Duckert A, 2010, EUR SOC MED ONC C MI

[7]

Patient-reported Measurements of Oral Mucositis in Head and Neck Cancer Patients Treated With Radiotherapy With or Without Chemotherapy Demonstration of Increased Frequency, Severity, Resistance to Palliation, and Impact on Quality of Life [J].

Elting, Linda S. ;

Keefe, Dorothy M. ;

Sonis, Stephen T. ;

Garden, Adam S. ;

Spijkervet, F. K. L. ;

Barasch, Andrei ;

Tishler, Roy B. ;

Canty, Thomas P. ;

Kudrimoti, Mahesh K. ;

Vera-Lionch, Montserrat .

CANCER, 2008, 113 (10) :2704-2713

[8]

Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire [J].

Epstein, Joel B. ;

Beaumont, Jennifer L. ;

Gwede, Clement K. ;

Murphy, Barbara ;

Garden, Adam S. ;

Meredith, Ruby ;

Le, Quynh-Thu ;

Brizel, David ;

Isitt, John ;

Cella, David .

CANCER, 2007, 109 (09) :1914-1922

[9]

THE ORAL COMPLICATIONS OF SPECIFIC ANTICANCER THERAPY [J].

HOLMES, S .

INTERNATIONAL JOURNAL OF NURSING STUDIES, 1991, 28 (04) :343-360

[10]

Murphy, Barbara A. ;

Beaumont, Jennifer L. ;

Isitt, John ;

Garden, Adam S. ;

Gwede, Clement K. ;

Trotti, Andy M. ;

Meredith, Ruby F. ;

Epstein, Joel B. ;

Le, Quynh-Thu ;

Brizel, David M. ;

Bellm, Lisa A. ;

Wells, Nancy ;

Cella, David .

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 2009, 38 (04) :522-532

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