Trial Outcomes & Findings for Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (NCT NCT04752384)
NCT ID: NCT04752384
Last Updated: 2025-04-20
Results Overview
The Brief Pain Inventory - Short Form (BPI-sf) is a nine-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity -- 0 being no pain and 10 being the pain as bad as you can imagine (within the previous 24 hours).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline up to Week 9
Results posted on
2025-04-20
Participant Flow
Participant milestones
| Measure |
Drug Treatment
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Drug Treatment
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Drug Treatment
n=20 Participants
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 9Population: Please note there were many subjects who did not fill out forms.
The Brief Pain Inventory - Short Form (BPI-sf) is a nine-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity -- 0 being no pain and 10 being the pain as bad as you can imagine (within the previous 24 hours).
Outcome measures
| Measure |
Drug Treatment
n=13 Participants
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
The Number of Subjects Who Achieve at Least a 30 Percent Decrease in Pain From Baseline in VAS Pain Score Calculated From BPI Questionnaire.
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 9Population: Many subjects did not wear the OM Pain App.
The Oral Mucositis (OM) Pain App is a smartphone application that was designed to permit subjects to key in pain severity using a visual analog 0-10 scale. The amount of pain that a subject feels ranges across a continuum from none (0) to an extreme amount of pain (10). The App is programed with an alarm to prompt the patient to record pain severity at prescribed intervals daily and through spontaneous patient input. Compliance is measured by subjects entering in a value four times a day into the OM Pain App.
Outcome measures
| Measure |
Drug Treatment
n=9 Participants
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
The Number of Subjects Who Achieve at Least a 30 Percent Decrease in Pain From Baseline in Average Daily Pain Score Calculated by OM Pain App.
|
3 Participants
|
Adverse Events
Drug Treatment
Serious events: 4 serious events
Other events: 19 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Drug Treatment
n=20 participants at risk
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
Gastrointestinal disorders
oral pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
dysphagia
|
10.0%
2/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
anorexia
|
15.0%
3/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
weight loss
|
10.0%
2/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
hypotension
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
dehydration
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
hypernatremia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
delirium
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
Other adverse events
| Measure |
Drug Treatment
n=20 participants at risk
The main objective of this study is to provide preliminary evidence that FDA approved dose of transdermal buprenorphine in conjunction with oral tramadol can provide adequate analgesia of radiation-induced mucositis pain during treatment and follow up period in head and neck cancer patients.
Buprenorphine: Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
Tramadol: Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
Oral Mucositis (OM) Pain App: Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
2/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
6/20 • Number of events 8 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
8/20 • Number of events 10 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Aphonia
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Chills
|
15.0%
3/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Constipation
|
60.0%
12/20 • Number of events 15 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
CPK increased
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
8/20 • Number of events 9 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Delirium
|
10.0%
2/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
55.0%
11/20 • Number of events 13 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Number of events 8 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
10/20 • Number of events 10 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dysarthria
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dysgeusia
|
70.0%
14/20 • Number of events 16 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dysphagia
|
45.0%
9/20 • Number of events 12 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Ear pain
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Edema limbs
|
10.0%
2/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
3/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Facial pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fatigue
|
65.0%
13/20 • Number of events 21 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Thick secretions
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
drooling
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Gingival pain
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.0%
2/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
cirrhosis
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Herpes simplex reactivation
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • Number of events 3 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypertension
|
25.0%
5/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
5/20 • Number of events 8 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
4/20 • Number of events 7 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
5/20 • Number of events 7 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
fever blister
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Lip infection
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Lymphedema
|
20.0%
4/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Lymphocyte count decreased
|
25.0%
5/20 • Number of events 10 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Mucositis oral
|
65.0%
13/20 • Number of events 20 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
thigh pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
65.0%
13/20 • Number of events 17 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
General disorders
Neck edema
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
4/20 • Number of events 4 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Neutrophil count decreased
|
15.0%
3/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral pain
|
35.0%
7/20 • Number of events 12 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Paresthesia
|
25.0%
5/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Platelet count decreased
|
30.0%
6/20 • Number of events 6 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Renal calculi
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Phlegm
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Head laceration/cuts
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Soft tissue Coccyx injury
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
knee abrasion
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
60.0%
12/20 • Number of events 13 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Thrush
|
35.0%
7/20 • Number of events 8 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
Tinnitus
|
35.0%
7/20 • Number of events 7 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • Number of events 10 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight loss
|
55.0%
11/20 • Number of events 18 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Number of events 2 • 12 weeks
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • Number of events 1 • 12 weeks
regular investigator assessment, regular laboratory testing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place