Two more sites were added to the B-OM trial. The t
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Posted On: 03/22/2017 9:19:45 PM
Two more sites were added to the B-OM trial. The total is now 15.
https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
There are also changes in primary and secondary outcome measures.
Before
Measure: Efficacy Assessed by Sequential WHO Oral Mucositis Score
Time Frame: 11 weeks
Description: Efficacy of the study drug oral rinse will be assessed by trained site personnel twice-weekly. The WHO OM Score will be the primary measure for assessment of presence and severity of OM.
After
Measure: Incidence of ulcerative and severe oral mucositis (WHO Grade ≥3)
Time Frame: 7 weeks
Description: Incidence of ulcerative and severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.
Measure: Incidence of Treatment-Emergent Adverse Events
Time Frame: 11 weeks
Description: Reporting of Adverse Events and severity of adverse events
https://clinicaltrials.gov/archive/NCT0232433...21/changes
Interim analysis must be close.
https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
There are also changes in primary and secondary outcome measures.
Before
Measure: Efficacy Assessed by Sequential WHO Oral Mucositis Score
Time Frame: 11 weeks
Description: Efficacy of the study drug oral rinse will be assessed by trained site personnel twice-weekly. The WHO OM Score will be the primary measure for assessment of presence and severity of OM.
After
Measure: Incidence of ulcerative and severe oral mucositis (WHO Grade ≥3)
Time Frame: 7 weeks
Description: Incidence of ulcerative and severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.
Measure: Incidence of Treatment-Emergent Adverse Events
Time Frame: 11 weeks
Description: Reporting of Adverse Events and severity of adverse events
https://clinicaltrials.gov/archive/NCT0232433...21/changes
Interim analysis must be close.
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