Phase 2 N=40 Cox-2 Inhibition in Radiation-induced Oral Mucositis
Oral Mucositis
Primary: Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy — 1.42; 1.36 units on a scale
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=19 Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
Oral Mucositis · Oral Cancer
Primary: Oral Mucositis Severity - WHO Scale — 3; 3; 0; 0 participants
Phase 2 N=223 A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
Radiation Induced Oral Mucositis
Primary: Duration (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) Criteria — 8; 1.5; 19 days
Phase 3 N=91 GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer · Mucositis Oral · Radiation Toxicity
Primary: Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) — 28; 46 participants — p=0.09
Phase 2 N=5 A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy
Mucositis · Head and Neck Cancer
Primary: Number of Participants With Adverse Events (AEs) — 2; 3; 0; 2 participants
Phase 3 N=94 Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Squamous Cell Carcinoma of Nasopharynx · Squamous Cell Carcinoma of Oropharynx · Squamous Cell Carcinoma of Hypopharynx
Primary: Incidence and / or Severity of Oral Mucositis — 19; 3 Grade 3-4 oral mucositis — p=0.05
Phase 2 N=53 Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
Oral Mucositis
Primary: Duration of Severe Oral Mucositis (SOM) — 22.9; 27.7; 35.2; 37.8 Days
Phase 2 N=50 Herbal Mouthrinse for Oral Mucositis Study
Oral Mucositis
Primary: Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily…
Phase 2 N=81 Efficacy of SNX-1012 in the Treatment of Oral Mucositis
Stomatitis · Oral Mucositis
Primary: Duration of Ulcerative Oral Mucositis — 2.3; 3.2 Days
Phase 2 N=6 A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
Head and Neck Cancer
Primary: Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events, as Assessed by CTCAE v 4.03…
Phase 3 N=455 ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Oral Mucositis
Primary: Cumulative Incidence of Severe Oral Mucositis — 53.8; 64.0 percentage of patients
Phase 2 N=72 Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer · Carcinoma, Squamous Cell · Neoplasms, Oral
Primary: Number of Patients With Solitary Elective Volume Recurrence — 0 Participants
N/A N=23 Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
Squamous Cell Carcinoma of the Head and Neck
Primary: Grade of Xerostomia — 1.14; 1.17 units on a scale
Phase 3 N=106 A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
Radiotherapy Induced Mucositis · Head and Neck Cancer
Primary: Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment — 14; 18 Participants
Phase 2 N=53 Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
Head and Neck Cancer · Radiotherapy
Primary: the Incidence Rate of Severe Radiation Mucositis — 3; 38; 5; 0 Participants
Phase 2 N=33 Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Head and Neck Cancer · Cancer of the Pharynx · Cancer of the Larynx
Primary: Llocoregional Recurrence — 27 Participants
N/A N=68 Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis
Oral Mucositis
Primary: Severity of Oral Mucositis — 27; 24; 0; 0 Participants — p=<0.05
N/A N=57 Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
Head and Neck Neoplasms
Primary: Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set) — 3; 9; 6; 18 Participants
N/A N=25 Low-Level Laser Therapy for Prevention of Oral Mucositis
Mucositis
Primary: Number of Participants With Severe (Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v. 4.0] Grade 3-5 Oral Mucositis in Patients Treated to a…
N/A N=47 Low-Level Laser Therapy for Prevention of Oral Mucositis
Mucositis
Primary: Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis — 23 percentage of participants
Phase 3 N=65 Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Oropharynx Cancer
Primary: Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up — 20.1; 29.1…
N/A N=43 Prevention of Oral Mucositis Using Photobiomodulation Therapy
Oral Mucositis
Primary: Feasibility of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic…
Phase 2 N=37 Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Head and Neck Cancer · Oral Mucositis
Primary: Incidence of Treatment Emergent AE's — 36; 12; 33; 35 Participants
Phase 2 N=59 Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Head and Neck Neoplasms · Mucositis
Primary: Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy — 15; 9; 10; 12 Participants
Phase 3 N=79 Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
Malignant Head and Neck Neoplasm · Mucositis · Radiation-Induced Disorder
Primary: Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) — 4.26; 3.68 score on a scale — p=0.004
Phase 2 N=20 Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients
Head and Neck Squamous Cell Carcinoma
Primary: The Number of Subjects Who Achieve at Least a 30 Percent Decrease in Pain From Baseline in VAS Pain Score Calculated From BPI Questionnaire. — 8 Participants
N/A N=80 Optimized Intensity Modulated Irradiation for Head and Neck Cancer
Head and Neck Cancer
Primary: Percentage of Participants With Grade 0-1 Observer-rated Dysphagia — 94 percentage of participants
Phase 3 N=266 DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx · Oral Mucositis
Primary: Duration of Severe Oral Mucositis (SOM) — 12.5; 20.0 days — p=0.1798
Phase 3 N=188 Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Mucositis · Solid Tumors · Stomatitis
Primary: Number of Participants With Severe (Grade 3 or 4) Oral Mucositis — 62; 51; 29; 43 participants — p=0.0410
Phase 2 N=30 Mesenchymal Stemcells for Radiation Induced Xerostomia
Xerostomia
Primary: Number of Participants With Adverse Events as a Measure of Safety — 0; 0 participants