Cancer, Leukemia, Lymphoma
Conditions
Keywords
Cancer, Oncology
Brief summary
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).
Interventions
DRUGpalifermin
Administered as one daily intravenous bolus.
RADIATIONTotal Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
DRUGCyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
DRUGEtoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
DRUGPlacebo
Administered as one daily intravenous bolus.
Sponsors
Amgen
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma * Minimum of 1.5 x 10\^6 CD34+ cells/kg cryopreserved and to be transplanted.
Exclusion criteria
* Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin) * Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis * Congestive heart failure as defined by New York Heart Association class III or IV. * History of or current diagnosis of pancreatitis * Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines) * Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines) * Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (DLCO) less than 50% of predicted. * Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Mouth and Throat Soreness Score | From the first day of study drug administration through Day 28 | The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question 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). A higher value in MTS AUC indicates worse self-assessed MTS. |
| Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Up to Day 28 | Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia. |
| Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | 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. |
| Duration of WHO Grade 2, 3 or 4 Oral Mucositis | Up to Day 28 | The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated 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. |
| Number of Participants With WHO Grade 4 Oral Mucositis | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. 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. |
| Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palifermin 60 µg/kg for 3 Days Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). | 11 |
| Palifermin 180 μg/kg on Day -1 Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. | 10 |
| Palifermin 180 μg/kg on Day -2 Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. | 13 |
| Palifermin 180 μg/kg on Day -3 Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. | 12 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Palifermin 180 μg/kg on Day -2 | Palifermin 180 μg/kg on Day -3 | Total | Palifermin 60 µg/kg for 3 Days | Palifermin 180 μg/kg on Day -1 |
|---|---|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 14.2 | 46.1 years STANDARD_DEVIATION 13.8 | 48.8 years STANDARD_DEVIATION 12.2 | 52.7 years STANDARD_DEVIATION 9.9 | 49.7 years STANDARD_DEVIATION 9.7 |
| Etoposide use No | 2 participants | 1 participants | 5 participants | 2 participants | 0 participants |
| Etoposide use Yes | 11 participants | 11 participants | 41 participants | 9 participants | 10 participants |
| Number of days of total body irradiation ≤ 2 days | 1 participants | 0 participants | 2 participants | 0 participants | 1 participants |
| Number of days of total body irradiation 3 days | 6 participants | 4 participants | 18 participants | 4 participants | 4 participants |
| Number of days of total body irradiation 4 days | 6 participants | 8 participants | 26 participants | 6 participants | 6 participants |
| Number of days of total body irradiation ≥ 5 days | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 1 participants | 4 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White or Caucasian | 12 participants | 10 participants | 41 participants | 11 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 11 Participants | 5 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 35 Participants | 6 Participants | 10 Participants |
| Type of diagnosis Acute lymphoblastic leukemia | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Type of diagnosis Acute myelogenous leukemia | 0 participants | 1 participants | 2 participants | 1 participants | 0 participants |
| Type of diagnosis Chronic lymphocytic leukemia | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Type of diagnosis Chronic myelogenous leukemia | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Type of diagnosis Hodgkin's disease | 4 participants | 4 participants | 9 participants | 0 participants | 1 participants |
| Type of diagnosis Leukemia | 0 participants | 2 participants | 4 participants | 2 participants | 0 participants |
| Type of diagnosis Multiple Myeloma | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Type of diagnosis Non-Hodgkin's lymphoma | 9 participants | 6 participants | 33 participants | 9 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 10 / 11 | 12 / 13 | 12 / 12 |
| serious Total, serious adverse events | 1 / 10 | 3 / 11 | 4 / 13 | 1 / 12 |
Outcome results
Primary
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. 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 frame: Up to Day 28
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Yes | 9 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Missing | 0 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | No | 2 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Yes | 6 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Missing | 1 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | No | 3 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | No | 9 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Yes | 4 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Yes | 9 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | No | 3 participants |
Secondary
Area Under the Curve (AUC) of Mouth and Throat Soreness Score
The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question 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). A higher value in MTS AUC indicates worse self-assessed MTS.
Time frame: From the first day of study drug administration through Day 28
Population: Primary analysis set with available MTS data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | 26.4 MTS score * days | Standard Deviation 22.4 |
| Palifermin 180 μg/kg on Day -1 | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | 45.1 MTS score * days | Standard Deviation 14.4 |
| Palifermin 180 μg/kg on Day -2 | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | 30.4 MTS score * days | Standard Deviation 18.6 |
| Palifermin 180 μg/kg on Day -3 | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | 30.9 MTS score * days | Standard Deviation 16.1 |
Secondary
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
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 frame: Up to Day 28
Population: Primary analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | 6.0 days | Standard Deviation 4.1 |
| Palifermin 180 μg/kg on Day -1 | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | 4.4 days | Standard Deviation 5.4 |
| Palifermin 180 μg/kg on Day -2 | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | 1.9 days | Standard Deviation 3.6 |
| Palifermin 180 μg/kg on Day -3 | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | 5.1 days | Standard Deviation 4.1 |
Secondary
Duration of WHO Grade 2, 3 or 4 Oral Mucositis
The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated 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 frame: Up to Day 28
Population: Primary analysis set with available OM assessment data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | 10.3 days | Standard Deviation 4.9 |
| Palifermin 180 μg/kg on Day -1 | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | 9.0 days | Standard Deviation 8.2 |
| Palifermin 180 μg/kg on Day -2 | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | 4.7 days | Standard Deviation 4.2 |
| Palifermin 180 μg/kg on Day -3 | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | 9.4 days | Standard Deviation 5.7 |
Secondary
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.
Time frame: Up to Day 28
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Yes | 7 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | No | 4 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | No | 3 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Yes | 7 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Yes | 7 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | No | 6 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Yes | 9 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | No | 3 participants |
Secondary
Number of Participants With WHO Grade 4 Oral Mucositis
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. 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 frame: Up to Day 28
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grade 4 Oral Mucositis | Yes | 5 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grade 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grade 4 Oral Mucositis | No | 6 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grade 4 Oral Mucositis | Yes | 5 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grade 4 Oral Mucositis | Missing | 1 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grade 4 Oral Mucositis | No | 4 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grade 4 Oral Mucositis | No | 11 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grade 4 Oral Mucositis | Yes | 2 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grade 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grade 4 Oral Mucositis | Yes | 3 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grade 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grade 4 Oral Mucositis | No | 9 participants |
Secondary
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. 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 frame: Up to Day 28
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Yes | 10 participants |
| Palifermin 60 µg/kg for 3 Days | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | No | 1 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | No | 1 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Yes | 8 participants |
| Palifermin 180 μg/kg on Day -1 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Missing | 1 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | No | 4 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Yes | 9 participants |
| Palifermin 180 μg/kg on Day -2 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Yes | 12 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Missing | 0 participants |
| Palifermin 180 μg/kg on Day -3 | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | No | 0 participants |