| Primary | Duration of Severe Oral Mucositis (WHO Grade 3 or 4) | Mean days of severe (WHO Grade 3 or 4) Mucositis. | Evaluable patients defined as patients with >= 11 daily WHO assessments. | Posted | | Mean | Standard Deviation | Number of days | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Incidence of Severe Oral Mucositis | Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm. | Evaluable patients defined as patients with >= 11 daily WHO assessments. | Posted | | Number | | percent of patients | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Oral Mucositis Daily Questionnaire (OMDQ) | Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales | Evaluable patients defined as patients with ≥11 daily WHO assessments. | Posted | | Mean | Standard Deviation | units on a scale * day | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents). | Opioid Administration = yes | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II) | Posted | | Number | | percentage of participants | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents). | Mean days of parenteral opioid analgesic use. | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Mean | Standard Deviation | Days | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents). | Morphine equivalent dose in mg/kg/day | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Median | Full Range | mg/kg/day of opioid analgesics | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Incidence of Total Parenteral Nutrition (TPN) Administration. | Total Parenteral Nutrition = yes | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Number | | percentage of participants | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Duration of Total Parenteral Nutrition (TPN) Administration. | Mean days of total parenteral nutrition (TPN) administration. | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Mean | Standard Deviation | Number of days | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Incidence of Febrile Neutropenia | Fever and Neutropenia = yes | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Number | | percentage of participants | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Incidence of Invasive Bacterial Infections | Invasive Bacterial Infection = yes | Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II). | Posted | | Number | | percentage of participants | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Secondary | Severity of Mucositis | Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain. | Evaluable patients defined as patients with ≥11 daily WHO assessments. | Posted | | Mean | Standard Deviation | units on a scale * day | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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| Other Pre-specified | Ancillary Validation Study of ChIMES | | Analysis is not performed at this time due to no available funding and no human resource allocated to this study. | Posted | | | | | | Day -1 (day prior to stem cell infusion) to Day 20 following transplantation. | | | | ID | Title | Description |
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| OG000 | Arm I (Placebo) | Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies | | OG001 | Arm II (Supersaturated Calcium Phosphate Rinse) | Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies |
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