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GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00293462
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Head and Neck Cancer
Mucositis
Radiation Toxicity
Interventions Biological: sargramostim
Other: oral salt and soda mouthwash
Enrollment 91
Recruitment Details Adult (> 18 years of age) with confirmed histopathological diagnosis of head and neck carcinoma were recruited at the UCSF Radiation Oncology Clinic, the Helen Diller Comprehensive Cancer Center, Saint Francis Medical Center in San Francisco, and Temple University Radiation Oncology Clinic in Philadelphia from May, 2005 to Dec, 2009.
Pre-assignment Details  
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Period Title: Overall Study
Started 31 29 31
Completed 24 21 21
Not Completed 7 8 10
Reason Not Completed
Withdrawal by Subject             4             3             6
Death             1             0             0
Lost to Follow-up             0             1             0
Change Treatment Regimen (ineligible)             1             0             0
Hypersensitive Reaction (to Salt & Soda)             0             1             0
Refuse Radiation Treatment             1             0             0
No Show             0             0             1
Went back to his home country             0             0             1
Blood clot after chemotherapy             0             0             1
Ischemic stroke after chemotherapy             0             0             1
Possible Tracheostomy leakage             0             1             0
Low radiation dose in oral cavity             0             1             0
Physician Decision             0             1             0
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG) Total
Hide Arm/Group Description Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis. Total of all reporting groups
Overall Number of Baseline Participants 31 29 31 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 31 participants 91 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  80.6%
26
  89.7%
26
  83.9%
77
  84.6%
>=65 years
6
  19.4%
3
  10.3%
5
  16.1%
14
  15.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 31 participants 91 participants
53.55  (13.73) 54.69  (12.22) 56.26  (11.29) 54.48  (12.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 31 participants 91 participants
Female
11
  35.5%
2
   6.9%
11
  35.5%
24
  26.4%
Male
20
  64.5%
27
  93.1%
20
  64.5%
67
  73.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 31 participants 91 participants
Hispanic or Latino
1
   3.2%
1
   3.4%
2
   6.5%
4
   4.4%
Not Hispanic or Latino
30
  96.8%
28
  96.6%
27
  87.1%
85
  93.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   6.5%
2
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 31 participants 91 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
10
  32.3%
6
  20.7%
5
  16.1%
21
  23.1%
Native Hawaiian or Other Pacific Islander
1
   3.2%
0
   0.0%
1
   3.2%
2
   2.2%
Black or African American
2
   6.5%
4
  13.8%
0
   0.0%
6
   6.6%
White
18
  58.1%
16
  55.2%
22
  71.0%
56
  61.5%
More than one race
0
   0.0%
3
  10.3%
0
   0.0%
3
   3.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
3
   9.7%
3
   3.3%
1.Primary Outcome
Title Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis
Hide Description Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.
Time Frame Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS)
Hide Arm/Group Description:
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Overall Number of Participants Analyzed 28 55
Measure Type: Number
Unit of Measure: participants
28 48
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: GM-CSF Group (GG), Arm II: Salt & Soda Group (SS)
Comments Fisher's exact two tailed test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments Two by two table was used. One cell had expected frequency test less than five, so Fisher’s exact two-tailed test was used.
2.Primary Outcome
Title Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes.
Hide Description To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.
Time Frame From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description:
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
Overall Number of Participants Analyzed 28 21 19
Mean (Standard Error)
Unit of Measure: Healing Days
65  (8.16) 71  (3.00) 70  (7.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: GM-CSF Group (GG), Arm II: Salt & Soda Group (SS), Arm III: Salt & Soda Switched to GM-CSF (SG)
Comments Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SG and SS. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Mantel Haenszel
Comments Log rank, breslow, tarone-ware, but use mantel cox log rank for this analysis
3.Secondary Outcome
Title Quality of Life During Radiation Therapy
Hide Description Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.
Time Frame at baseline, during radiation therapy, and once a month for 3 months after radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description:
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
Overall Number of Participants Analyzed 28 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.91  (1.59) 6.80  (1.46) 6.77  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: GM-CSF Group (GG), Arm II: Salt & Soda Group (SS), Arm III: Salt & Soda Switched to GM-CSF (SG)
Comments Multilevel regression was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments 0.28 (quadratic)
Method Mixed Models Analysis
Comments Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.
4.Secondary Outcome
Title Functional Status by Karnofsky Performance Status Scale
Hide Description Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.
Time Frame baseline through 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description:
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
Overall Number of Participants Analyzed 28 25 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
84.52  (12.61) 82.93  (10.92) 83.49  (12.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: GM-CSF Group (GG), Arm II: Salt & Soda Group (SS), Arm III: Salt & Soda Switched to GM-CSF (SG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments 0.78 (quadratic)
Method Mixed Models Analysis
Comments Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.
5.Secondary Outcome
Title Pain Questionnaire
Hide Description Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.
Time Frame baseline through 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description:
Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
Overall Number of Participants Analyzed 27 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.15  (2.40) 1.72  (2.26) 2.15  (2.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: GM-CSF Group (GG), Arm II: Salt & Soda Group (SS), Arm III: Salt & Soda Switched to GM-CSF (SG)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments 0.22 (quadratic)
Method Mixed Models Analysis
Comments Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.
Time Frame From onset of mucositis, or after the start date of study medication to the follow-up period of the study.
Adverse Event Reporting Description Serious Adverse Events and adverse events were collected in the safety population, comprised of all participants who were randomized and received at least one dose of the study medication. Number of participants at risk represents the number of participants who received study medications.
 
Arm/Group Title Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Hide Arm/Group Description Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals. Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
All-Cause Mortality
Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/29 (6.90%)      2/28 (7.14%)      2/28 (7.14%)    
Gastrointestinal disorders       
Mucositis Oral  1 [1]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Lower gastrointestinal hemorrhage  1  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
General disorders       
Other  1 [2]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Death  1 [3]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Immune system disorders       
Allergic reaction  1 [4]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Vascular disorders       
Thromboembolic event  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Mucositis Oral:Hypersensitivity Reaction from Salt and Soda Mouthwash
[2]
Other (withdrawal symptoms-opioid)
[3]
Death-not associated with study-Disease progression
[4]
reactive oral mucositis : Due to the timing of the AE, the study team determined that the reactive oral mucositis is unlikely to be related to radiation therapy and was part of the salt and soda group.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Arm I: GM-CSF Group (GG) Arm II: Salt & Soda Group (SS) Arm III: Salt & Soda Switched to GM-CSF (SG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/29 (62.07%)      26/28 (92.86%)      27/28 (96.43%)    
Blood and lymphatic system disorders       
Transfusion  1  2/29 (6.90%)  2 0/28 (0.00%)  0 0/28 (0.00%)  0
Anemia  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Febrile neutropenia  1  1/29 (3.45%)  1 1/28 (3.57%)  1 1/28 (3.57%)  1
Cardiac disorders       
Sinus Tachycardia  1 [1]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders       
Stomach pain  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Constipation  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
General disorders       
Fatigue  1  1/29 (3.45%)  1 1/28 (3.57%)  1 1/28 (3.57%)  1
Pain  1 [2]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Other  1 [3]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Infections and infestations       
Wound infection  1 [4]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Sinusitis  1  0/29 (0.00%)  0 1/28 (3.57%)  3 0/28 (0.00%)  0
Infection  1 [5]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Injury, poisoning and procedural complications       
Fall  1 [6]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Radiation dermatitis  1  1/29 (3.45%)  1 1/28 (3.57%)  1 1/28 (3.57%)  4
Investigations       
Weight loss  1 [7]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Metabolism and nutrition disorders       
Dehydration  1 [8]  5/29 (17.24%)  16 13/28 (46.43%)  27 10/28 (35.71%)  21
Musculoskeletal and connective tissue disorders       
Exostosis  1 [9]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Nervous system disorders       
Ischemia Cerebrovascular  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Renal and urinary disorders       
Acute kidney Injury  1  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia  1  1/29 (3.45%)  1 1/28 (3.57%)  1 0/28 (0.00%)  0
Other  1 [10]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Dyspnea  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Laryngopharyngeal Dyesthesia  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Laryngeal obstruction  1 [11]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Laryngeal edema  1 [12]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1 [13]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Rash acne form  1  0/29 (0.00%)  0 1/28 (3.57%)  2 1/28 (3.57%)  2
Surgical and medical procedures       
Other  1 [14]  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Other  1 [15]  0/29 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2
Other  1 [16]  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Other  1 [17]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Other  1 [18]  0/29 (0.00%)  0 1/28 (3.57%)  1 1/28 (3.57%)  1
Other  1 [19]  0/29 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Sinus tachycardia due to Acetaminophen-codene medication.
[2]
(Shoulder and neck area)
[3]
(Withdraweal symptoms-opioid)
[4]
(Right foot)
[5]
(left parotid gland)
[6]
(bicycle accident)
[7]
(>15 lbs; more than 10%)
[8]
(hydrated at doctor's office during/after radiation treatment)
[9]
Had the potential to have bone growth and had previous history. Based on physician's decision. Patient was in Salt and Soda group. This was not related to the mouth wash medication.
[10]
(chest congestion)
[11]
(mucous)
[12]
(Asymptomatic; clinical observations only; intervention not indicated; tracheostomy area)
[13]
(due to fentanyl patch)
[14]
(lung biopsy)
[15]
(Percutaneous endoscopic gastrostomy tube insertion)
[16]
(PEG tube removal)
[17]
(basal cell carcinoma remove from thumb)
[18]
(facial reconstruction)
[19]
(Septoplasty)
Of 532 potential subjects that were screened, 374 were excluded as they did not meet the inclusion criteria, 45 refused to participate and 22 were no-shows (declined radiation therapy), thereby reducing our original target sample population to 91.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marylin J. Dodd, RN, PhD, FAAN
Organization: University of California, San Francisco
Phone: 415-476-2191
EMail: Marylin.dodd@nursing.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00293462     History of Changes
Other Study ID Numbers: CDR0000459510
UCSF-H452-26184-03 ( Other Identifier: IRB approval number )
FCCC-4626 ( Other Identifier: UCSF Cancer Center )
First Submitted: February 16, 2006
First Posted: February 17, 2006
Results First Submitted: March 27, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 16, 2013