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

Cancer

Volumn 120, Issue 9, 2014, Pages 1433-1440

  Allison, Ron R ^a   Ambrad, Aaron A ^b   Arshoun, Youssef ^c   Carmel, Richard J ^d   Ciuba, Doug F ^e   Feldman, Elizabeth ^f   Finkelstein, Steven E ^a   Gandhavadi, Ranjini ^g   Heron, Dwight E ^h   Lane, Steven C ⁱ   Longo, John M ^j   Meakin, Charles ^k   Papadopoulos, Dimitrios ^l   Pruitt, David E ^m   Steinbrenner, Lynn M ⁿ   Taylor, Michael A ^o   Wisbeck, William M ^p   Yuh, Grace E ^q   Nowotnik, David P ^r   Sonis, Stephen T ^s  

^a 21ST CENTURY ONCOLOGY   (United States)

^b Ironwood Research Centers   (United States)

^c ALLEGHENY GENERAL HOSPITAL   (United States)

^d John Muir Health   (United States)

^e Amos Cancer Center   (United States)

^f M D ANDERSON CANCER CENTER ORLANDO   (United States)

^g Medical College of Wisconsin   (United States)

^h UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

ⁱ Signature Healthcare Brockton Hospital   (United States)

^j MISSOURI VALLEY CANCER CONSORTIUM   (United States)

^k CaroMont Health Comprehensive Cancer Center   (United States)

^l Vassar Brothers Medical Center   (United States)

^m St Joseph's Mercy Health Center Hot Springs   (United States)

ⁿ VA Western New York Health System   (United States)

^o PeaceHealth St Joseph Medical Center   (United States)

^p Providence Regional Medical Center   (United States)

^q Enloe Medical Center   (United States)

^r Access Pharmaceuticals Inc   (United States)

^s Clinical Assistance Programs LLC   (United States)

more..

Author keywords

chemoradiation; head and neck cancer; mucoadhesive gel; mucositis

Indexed keywords

MOUTHWASH; OPIATE;

ADULT; ADVERSE OUTCOME; AGED; ARTICLE; CHEMORADIOTHERAPY; CONSTIPATION; CONTROLLED STUDY; DEHYDRATION; DEVICE SAFETY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG USE; FEBRILE NEUTROPENIA; FEMALE; HEAD AND NECK CANCER; HEMOPTYSIS; HUMAN; HYDROGEL; MAJOR CLINICAL STUDY; MALE; MOUTH PAIN; NAUSEA; ORAL MUCOSITIS; PATIENT COMPLIANCE; PRIMARY TUMOR; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; SYMPTOM; TREATMENT DURATION; VERY ELDERLY; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; CARCINOMA, SQUAMOUS CELL; CHEMORADIOTHERAPY; DOUBLE-BLIND METHOD; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; HYDROGEL; MALE; MIDDLE AGED; MOUTH MUCOSA; NEOPLASM STAGING; PLACEBOS; STOMATITIS;

EID: 84899476322     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28553     Document Type: Article

References (20)

1. Raber-Durlacher JE, Elad S, Barasch A,. Oral mucositis. Oral Oncol. 2010; 46: 452-456.
2. Sonis ST,. Mucositis: the impact, biology and therapeutic opportunities of oral mucositis. Oral Oncol. 2009; 45: 1015-1020.
3. Elting LS, Keefe DM, Sonis ST, et al. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy. Cancer. 2008; 113: 2704-2713.
4. Murphy BA, Beaumont JL, Isitt J, et al. Mucositis-related morbidity and resource utilization in head and neck cancer patients receiving radiation therapy with or without chemotherapy. J Pain Symptom Manage. 2009; 38: 522-532.
5. Nonzee NJ, Dandade NA, Markossian T, et al. Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis. Cancer. 2008; 113: 1446-1452.
6. Nicolatou-Galitis O, Sarri T, Bowen J, et al. Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients. Support Care Cancer. 2013; 21: 3179-3189.
7. Chan A, Ignoffo RJ,. Survey of topical oral solutions for the treatment of chemo-induced oral mucositis. J Oncol Pharm Pract. 2005; 11: 139-143.
8. Dodd MJ, Dibble SL, Miaskowski C, et al. Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000; 90: 39-47.
9. Baud CM, Colon LE, Gerberich J, Nowotnik DP, Howell SB,. Protection from Radiation-Induced Oral Mucositis by MuGard™ Oral Rinse. A Clinical Study and in silico Analysis, MASCC/ISOO International Symposium, Toronto, Canada: 2006.
10. Duckert A, Wildfang I, Riesenbeck D, Friesland S, Gunnarsson K, Collucci M, Maisto C, Dumas C,. Management of oral mucositis (OM) with a muco-adhesive oral rinse: European clinical experience. European Society for Medical Oncology Congress, Milan, 2010.
11. Stiff PJ, Erder H, Bensinger WI, et al. Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant. 2006; 37: 393-401.
12. Bateman E, Keefe D,. Patient-reported outcomes in supportive care. Semin Oncol. 2011; 38: 358-361.
13. Stiff PJ, Emmanouilides C, Bensinger WI, et al. Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. J Clin Oncol. 2006; 24: 5186-5193.
14. Holmes S,. The oral complications of specific anticancer therapy. Int J Nurs Stud. 1991; 28: 343-360.
15. Epstein JB, Beaumont JL, Gwede CK, et al. Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer. 2007; 109: 1914-1922.
16. National Cancer Institute. Oral Complications of Chemotherapy and Head/Neck Radiation (PDQ®). http://www.cancer.gov/cancertopics/pdq/ supportivecare/oralcomplications/HealthProfessional/page1/AllPages. Accessed January 9, 2014.
17. Platek ME, Myrick E, McCloskey SA, et al. Pretreatment weight status and weight loss among head and neck cancer patients receiving definitive concurrent chemoradiation therapy: implications for nutrition integrated treatment pathways. Support Care Cancer. 2013; 21: 2825-2833.
18. Thorpe D, Stringer A, Butler R,. Chemotherapy-induced mucositis: The role of mucin secretion and regulation, and the enteric nervous system. Neurotoxicology. 2013; 38C: 101-105.
19. Stringer AM, Gibson RJ, Logan RM, et al. Irinotecan-induced mucositis is associated with changes in intestinal mucins. Cancer Chemother Pharmacol. 2008; 64: 123-132.
20. Daly CF,. Easing the effects of radiation to the head and neck. Oncol Nurs Advisor. October 2013 issue. Posted August 21, 2013. www. oncologynurseadvisor.com.