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Trial record 2 of 16 for:    dry mouth AND Radiation Toxicity | NIH

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00068237
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : January 31, 2014
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Head and Neck Cancer
Radiation Toxicity
Xerostomia
Interventions Procedure: salivary gland transfer
Radiation: Post-operative radiation therapy
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Period Title: Overall Study
Started 49
Completed 44 [1]
Not Completed 5
Reason Not Completed
Ineligible             3
No protocol treatment received             2
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
All eligible patients who started study treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
56.5
(42 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
8
  18.2%
Male
36
  81.8%
1.Primary Outcome
Title Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"
Hide Description Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
Time Frame At the time of the submandibular salivary gland transfer
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment.
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
34
2.Secondary Outcome
Title Percentage of Patients With Acute Xerostomia
Hide Description The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).
Time Frame From start of treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started RT
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.6
(12.5 to 38.6)
3.Secondary Outcome
Title Percentage of Patients With Normal Functioning Transferred Submandibular Gland
Hide Description Salivary gland functioning classified as "Non-functioning", "Minimal function", "Well-functioning but some impairment", "Normal functioning", or "Other" is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained.
Time Frame Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with salivary scans submitted
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Pre-surgery Number Analyzed 37 participants
70.3
(55.5 to 85.0)
Post-surgery Number Analyzed 36 participants
16.7
(4.5 to 28.8)
Post-radiotherapy Number Analyzed 27 participants
0.0
(0.0 to 0.0)
4.Secondary Outcome
Title Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire
Hide Description The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.
Time Frame Baseline and one year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and 1-year questionnaire completed
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 22
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
13.6
(7.7 to 16.5)
5.Secondary Outcome
Title Percentage of Patients Experiencing Facial Edema Following Surgery
Hide Description Facial edema was noted as present or absent following surgery.
Time Frame From surgery to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received the procedure
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.6
(3.5 to 23.8)
6.Secondary Outcome
Title Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy
Hide Description Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Acute" refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy.
Time Frame From start of radiation therapy to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started RT
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.9
(20.6 to 49.1)
7.Secondary Outcome
Title Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy
Hide Description Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. "Late" refers to toxicities occurring at least 91 days from the start of radiation therapy.
Time Frame From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started RT and had toxicity data at least 90 days from the end of RT
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.9
(0.0 to 16.5)
8.Secondary Outcome
Title Disease-free Survival Rate at 2 Years
Hide Description Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.7
(58.2 to 85.3)
9.Secondary Outcome
Title Overall Survival Rate at 2 Years
Hide Description Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description:
Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.4
(63.6 to 89.2)
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Please note that different numbers of patients were at risk for different treatment-specific adverse events due to the timing and sequence of treatments.
 
Arm/Group Title Surgery + Transfer + Radiation
Hide Arm/Group Description Submandibular salivary gland transfer at the time of surgery for the primary tumor and neck nodes followed by post-operative radiation therapy.
All-Cause Mortality
Surgery + Transfer + Radiation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Surgery + Transfer + Radiation
Affected / at Risk (%)
Total   2/44 (4.55%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/43 (2.33%) 
Psychiatric disorders   
Confusion * 1  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
Apnoea * 1  1/43 (2.33%) 
Surgical and medical procedures   
Acute Surgical Complication: Bleeding/hematoma   2/44 (4.55%) 
Acute Surgical Complication: Cerebral embolism/CVA   1/44 (2.27%) 
Acute Surgical Complication: Wound infection   2/44 (4.55%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery + Transfer + Radiation
Affected / at Risk (%)
Total   38/44 (86.36%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  4/43 (9.30%) 
Lymphatics-Other * 1  1/43 (2.33%) 
Ear and labyrinth disorders   
Hearing impaired * 1  2/43 (4.65%) 
Hearing-Other * 1  3/43 (6.98%) 
Endocrine disorders   
Hypothyroidism * 1  1/43 (2.33%) 
Gastrointestinal disorders   
Constipation * 1  2/43 (4.65%) 
Diarrhea NOS * 1  2/43 (4.65%) 
Dry mouth  1  26/43 (60.47%) 
Dysphagia * 1  6/43 (13.95%) 
Esophageal spasm * 1  1/43 (2.33%) 
Esophagitis NOS * 1  6/43 (13.95%) 
GI-other * 1  3/43 (6.98%) 
Gastric ulcer * 1  1/43 (2.33%) 
Nausea * 1  10/43 (23.26%) 
Radiation mucositis * 1  14/43 (32.56%) 
Salivary gland disorder NOS  1  18/43 (41.86%) 
Stomatitis * 1  3/43 (6.98%) 
Vomiting NOS * 1  7/43 (16.28%) 
General disorders   
Chest pain * 1  1/43 (2.33%) 
Fatigue * 1  17/43 (39.53%) 
Infection NOS * 1  1/43 (2.33%) 
Late RT Toxicity: Esophagus  2  4/38 (10.53%) 
Late RT Toxicity: Joint  2  3/38 (7.89%) 
Late RT Toxicity: Larynx  2  6/38 (15.79%) 
Late RT Toxicity: Mucous Membrane  2  9/38 (23.68%) 
Late RT Toxicity: Other  2  10/38 (26.32%) 
Late RT Toxicity: Salivary Gland (xerostomia, taste impairme  2  22/38 (57.89%) 
Late RT Toxicity: Skin (within XRT field)  2  6/38 (15.79%) 
Late RT Toxicity: Subcutaneous Tissue (Within XRT field)  2  6/38 (15.79%) 
Pain due to radiation * 1  11/43 (25.58%) 
Pain-other * 1  8/43 (18.60%) 
Pyrexia * 1  2/43 (4.65%) 
Rigors * 1  1/43 (2.33%) 
Immune system disorders   
Allergy-Other * 1  1/43 (2.33%) 
Infections and infestations   
Infection, Other * 1  5/43 (11.63%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS * 1  12/43 (27.91%) 
Investigations   
Blood creatinine increased * 1  1/43 (2.33%) 
Leukopenia NOS * 1  3/43 (6.98%) 
Weight decreased * 1  12/43 (27.91%) 
Metabolism and nutrition disorders   
Anorexia * 1  7/43 (16.28%) 
Blood albumin decreased * 1  1/43 (2.33%) 
Blood magnesium decreased * 1  1/43 (2.33%) 
Dehydration * 1  5/43 (11.63%) 
Hypokalemia * 1  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other * 1  5/43 (11.63%) 
Muscle weakness NOS * 1  1/43 (2.33%) 
Nervous system disorders   
Depressed level of consciousness * 1  1/43 (2.33%) 
Peripheral motor neuropathy * 1  1/43 (2.33%) 
Peripheral sensory neuropathy * 1  1/43 (2.33%) 
Taste disturbance  1  23/43 (53.49%) 
Psychiatric disorders   
Anxiety NEC * 1  2/43 (4.65%) 
Insomnia NEC * 1  2/43 (4.65%) 
Reproductive system and breast disorders   
Sexual/reproductive function-Other * 1  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  5/43 (11.63%) 
Dysphonia * 1  2/43 (4.65%) 
Dyspnea NOS * 1  5/43 (11.63%) 
Hemoptysis * 1  2/43 (4.65%) 
Hypoxia * 1  1/43 (2.33%) 
Pulmonary-other * 1  2/43 (4.65%) 
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative NOS * 1  6/43 (13.95%) 
Erythema multiforme * 1  1/43 (2.33%) 
Skin discoloration * 1  1/43 (2.33%) 
Skin-Other * 1  2/43 (4.65%) 
Surgical and medical procedures   
Acute Surgical Complication: Facial edema   6/44 (13.64%) 
Acute Surgical Complication: Facial edema on the transfer si   6/44 (13.64%) 
Acute Surgical Complication: Gland movement out of position   1/44 (2.27%) 
Acute Surgical Complication: Neck numbness   3/44 (6.82%) 
Acute Surgical Complication: Neck numbness on the transfer s   2/44 (4.55%) 
Acute Surgical Complication: Nerve injury: hypoglossal   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: hypoglossal on th   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: lingual   1/44 (2.27%) 
Acute Surgical Complication: Other   4/44 (9.09%) 
Acute Surgical Complication: Shoulder weakness   2/44 (4.55%) 
Acute Surgical Complication: Shoulder weakness on the transf   1/44 (2.27%) 
Late Surgical Complication: Other   10/44 (22.73%) 
Late Surgical Complication: Recurrent adenitis   1/44 (2.27%) 
Late Surgical Complication: Submental fullness   8/44 (18.18%) 
Vascular disorders   
Edema NOS * 1  3/43 (6.98%) 
Hemorrhage-Other * 1  1/43 (2.33%) 
Lymphangiopathy NOS * 1  2/43 (4.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
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
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00068237     History of Changes
Other Study ID Numbers: RTOG-0244
CDR0000287213
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: October 29, 2013
Results First Posted: January 31, 2014
Last Update Posted: February 5, 2019