TriangleNCT01305200 · STUDY IN CONTEXT
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
Opioid Administration = yes
Mean days of parenteral opioid analgesic use.
Morphine equivalent dose in mg/kg/day
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- trial label
- Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0000
- source section id
- NCT01305200-om-0000
- source outcome index
- 0
- endpoint
- Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
- endpoint definition
- Mean days of severe (WHO Grade 3 or 4) Mucositis.
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable patients defined as patients with \>= 11 daily WHO assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0001
- source section id
- NCT01305200-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Severe Oral Mucositis
- endpoint definition
- Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable patients defined as patients with \>= 11 daily WHO assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0002
- source section id
- NCT01305200-om-0002
- source outcome index
- 2
- endpoint
- Oral Mucositis Daily Questionnaire (OMDQ)
- endpoint definition
- Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable patients defined as patients with ≥11 daily WHO assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0003
- source section id
- NCT01305200-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).
- endpoint definition
- Opioid Administration = yes
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0004
- source section id
- NCT01305200-om-0004
- source outcome index
- 4
- endpoint
- Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).
- endpoint definition
- Mean days of parenteral opioid analgesic use.
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0005
- source section id
- NCT01305200-om-0005
- source outcome index
- 5
- endpoint
- Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
- endpoint definition
- Morphine equivalent dose in mg/kg/day
- time origin
- Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 106
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 106
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (Placebo)
- regimen
- 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
- analyzed count
- 106
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- regimen
- 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
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01305200-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- harm key
- EG000
- source section id
- NCT01305200-ae
- event group key
- EG000
- event group label
- Arm I (Placebo)
- serious affected
- 0
- serious at risk
- 106
- other affected
- 29
- other at risk
- 106
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT01305200
- harm key
- EG001
- source section id
- NCT01305200-ae
- event group key
- EG001
- event group label
- Arm II (Supersaturated Calcium Phosphate Rinse)
- serious affected
- 3
- serious at risk
- 104
- other affected
- 22
- other at risk
- 104
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Total of 210 patients evaluable for toxicity (106 Arm I \& 104 Arm II). Reasons for exclusion from this population include 3 ineligibles, 3 not randomized, 10 off before starting study/treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice