Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

NCT01066741 | Terminated Phase 3

• 2 other identifiers: HOMEODENTET2006-042
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer. This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

Conditions

Oropharynx Cancer; Hypopharynx Cancer

Keywords

Epidermoid carcinoma; Hypopharynx; Oropharynx; Oral cavity; Oral mucosa; Cavum; Severe Oral mucositis; Radiotherapy; Phytotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)

  At the end of irradiation period (6 weeks)

Secondary Outcomes (9)

• Rate of grade ≥2 mucositis

  At the end of irradiation period (6 weeks)

• Rate of Mycosis and Herpes virus infection

  At the end of irradiation period (6 weeks)

• Rate of use of symptomatic treatment in case of occurrence of mucositis

  At the end of irradiation period (6 weeks)

• Rate and duration of radiation treatment interruption for toxicity

  At the end of irradiation period (6 weeks)

• radiation dose, duration of grade ≥3 mucositis, maximum weight loss and maximum level of oral pain in case of grade ≥3 mucositis.

  during the occurence of grade≥3 mucositis

Study Arms (2)

Homeodent®

EXPERIMENTAL

Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation.

Drug: Homeodent®

1.4 % Sodium Bicarbonate solution

ACTIVE COMPARATOR

Mouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation. In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis.

Drug: 1.4% Sodium Bicarbonate solution

Interventions

Homeodent® DRUG

Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.

Homeodent®

1.4% Sodium Bicarbonate solution DRUG

Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

1.4 % Sodium Bicarbonate solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged ≥ 18 years
• ECOG PS ≤ 2
• Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage
• Patient receiving a minimum radiation dose of 60 Gy
• Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx
• Mandatory affiliation with a health insurance system
• Signed, written informed consent

You may not qualify if:

• Previous irradiation to the oral mucosa and/or oropharynx
• Pre-existing mucositis
• Pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential)
• Patient included in another study including experimental radiotherapy possibly toxic to the mucosa
• difficult follow up of the patient
• patient deprived of civil rights

Sponsors & Collaborators

• Centre Leon Berard: lead
• BOIRON: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, France

Location

Related Publications (17)

• Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.

  PMID: 12742264 BACKGROUND

• Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy: part 1, pathogenesis and prophylaxis of mucositis. Head Neck. 2003 Dec;25(12):1057-70. doi: 10.1002/hed.10318.

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• Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.

  PMID: 15782422 BACKGROUND

• Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy. Part 2: diagnosis and management of mucositis. Head Neck. 2004 Jan;26(1):77-84. doi: 10.1002/hed.10326.

  PMID: 14724910 BACKGROUND

• Lapeyre M, Charra-Brunaud C, Kaminsky MC, Geoffrois L, Dolivet G, Toussaint B, Maire F, Pourel N, Simon M, Marchal C, Bey P. [Management of mucositis following radiotherapy for head and neck cancers]. Cancer Radiother. 2001 Nov;5 Suppl 1:121s-130s. French.

  PMID: 11797271 BACKGROUND

• Worthington HV, Clarkson JE, Eden OB. Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2004;(2):CD001973. doi: 10.1002/14651858.CD001973.pub2.

  PMID: 15106165 BACKGROUND

• Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD000978. doi: 10.1002/14651858.CD000978.pub2.

  PMID: 16625538 BACKGROUND

• Trotti A, Garden A, Warde P, Symonds P, Langer C, Redman R, Pajak TF, Fleming TR, Henke M, Bourhis J, Rosenthal DI, Junor E, Cmelak A, Sheehan F, Pulliam J, Devitt-Risse P, Fuchs H, Chambers M, O'Sullivan B, Ang KK. A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):674-81. doi: 10.1016/S0360-3016(03)01627-4.

  PMID: 14967419 BACKGROUND

• El-Sayed S, Nabid A, Shelley W, Hay J, Balogh J, Gelinas M, MacKenzie R, Read N, Berthelet E, Lau H, Epstein J, Delvecchio P, Ganguly PK, Wong F, Burns P, Tu D, Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J Clin Oncol. 2002 Oct 1;20(19):3956-63. doi: 10.1200/JCO.2002.05.046.

  PMID: 12351592 BACKGROUND

• Dodd MJ, Miaskowski C, Greenspan D, MacPhail L, Shih AS, Shiba G, Facione N, Paul SM. Radiation-induced mucositis: a randomized clinical trial of micronized sucralfate versus salt & soda mouthwashes. Cancer Invest. 2003;21(1):21-33. doi: 10.1081/cnv-120016400.

  PMID: 12643006 BACKGROUND

• Stokman MA, Spijkervet FK, Burlage FR, Dijkstra PU, Manson WL, de Vries EG, Roodenburg JL. Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial. Br J Cancer. 2003 Apr 7;88(7):1012-6. doi: 10.1038/sj.bjc.6600824.

  PMID: 12671696 BACKGROUND

• Saarilahti K, Kajanti M, Joensuu T, Kouri M, Joensuu H. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):479-85. doi: 10.1016/s0360-3016(02)02935-8.

  PMID: 12243825 BACKGROUND

• Warde P, O'Sullivan B, Aslanidis J, Kroll B, Lockwood G, Waldron J, Payne D, Bayley A, Ringash J, Kim J, Liu FF, Maxymiw W, Sprague S, Cummings BJ. A Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):9-13. doi: 10.1016/s0360-3016(02)02890-0.

  PMID: 12182969 BACKGROUND

• Epstein JB, Silverman S Jr, Paggiarino DA, Crockett S, Schubert MM, Senzer NN, Lockhart PB, Gallagher MJ, Peterson DE, Leveque FG. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001 Aug 15;92(4):875-85. doi: 10.1002/1097-0142(20010815)92:43.0.co;2-1.

  PMID: 11550161 BACKGROUND

• Ertekin MV, Koc M, Karslioglu I, Sezen O. Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study. Int J Radiat Oncol Biol Phys. 2004 Jan 1;58(1):167-74. doi: 10.1016/s0360-3016(03)01562-1.

  PMID: 14697435 BACKGROUND

• Maiche AG, Grohn P, Maki-Hokkonen H. Effect of chamomile cream and almond ointment on acute radiation skin reaction. Acta Oncol. 1991;30(3):395-6. doi: 10.3109/02841869109092392. No abstract available.

  PMID: 2036252 BACKGROUND

• Fidler P, Loprinzi CL, O'Fallon JR, Leitch JM, Lee JK, Hayes DL, Novotny P, Clemens-Schutjer D, Bartel J, Michalak JC. Prospective evaluation of a chamomile mouthwash for prevention of 5-FU-induced oral mucositis. Cancer. 1996 Feb 1;77(3):522-5. doi: 10.1002/(SICI)1097-0142(19960201)77:33.0.CO;2-6.

  PMID: 8630960 BACKGROUND

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Carcinoma, Squamous Cell; Stomatitis

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Mouth Diseases

Study Officials

• Pascal POMMIER

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 10, 2010
• Study Start: May 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

FR (1)