TriangleNCT00101582 · STUDY IN CONTEXT
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
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. 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
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.
The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.
The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
The total dose of opioid analgesics (mg of intravenous \[IV\] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents.
Reported safety
Quality of life and patient-reported measures
Patient-reported symptom or function measure · Patient-Reported Mouth and Throat Soreness Score
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- qol key
- qol-0004
- source section id
- NCT00101582-om-0004
- source outcome index
- 4
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Patient-Reported Mouth and Throat Soreness Score
- measure definition
- The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
- time frame
- Assessed twice a week for up to 15 weeks.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either: * At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or * 70% or greater overall compliance for MTS until withdrawal/Week 8.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- trial label
- Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
- 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.
- 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
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0000
- source section id
- NCT00101582-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
- endpoint definition
- Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
- time origin
- Up to Week 15
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set included all randomized participants.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0001
- source section id
- NCT00101582-om-0001
- source outcome index
- 1
- endpoint
- Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
- endpoint definition
- The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
- time origin
- Up to 15 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0002
- source section id
- NCT00101582-om-0002
- source outcome index
- 2
- endpoint
- Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
- endpoint definition
- Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.
- time origin
- Up to 15 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0003
- source section id
- NCT00101582-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
- endpoint definition
- The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.
- time origin
- Month 4
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0004
- source section id
- NCT00101582-om-0004
- source outcome index
- 4
- endpoint
- Patient-Reported Mouth and Throat Soreness Score
- endpoint definition
- The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
- time origin
- Assessed twice a week for up to 15 weeks.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either: * At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or * 70% or greater overall compliance for MTS until withdrawal/Week 8.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0005
- source section id
- NCT00101582-om-0005
- source outcome index
- 5
- endpoint
- Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
- endpoint definition
- The total dose of opioid analgesics (mg of intravenous \[IV\] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents.
- time origin
- Up to 15 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Palifermin
- regimen
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- analyzed count
- 94
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00101582-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- harm key
- EG000
- source section id
- NCT00101582-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 25
- serious at risk
- 91
- other affected
- 81
- other at risk
- 91
- frequency threshold
- 5
- collection period
- Approximately 8 weeks
- event definition
- The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- harm key
- EG001
- source section id
- NCT00101582-ae
- event group key
- EG001
- event group label
- Palifermin
- serious affected
- 35
- serious at risk
- 94
- other affected
- 89
- other at risk
- 94
- frequency threshold
- 5
- collection period
- Approximately 8 weeks
- event definition
- The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00101582
- qol key
- qol-0004
- source section id
- NCT00101582-om-0004
- source outcome index
- 4
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Patient-Reported Mouth and Throat Soreness Score
- measure definition
- The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
- time frame
- Assessed twice a week for up to 15 weeks.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either: * At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or * 70% or greater overall compliance for MTS until withdrawal/Week 8.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice