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Trial record 8 of 64 for:    dry mouth | 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 17, 2017
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: Surgery for the primary and neck nodes
Procedure: Submandibular salivary gland transfer
Radiation: Post-operative radiation therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Surgery and Salivary Gland Transfer and Radiation Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.

Participant Flow:   Overall Study
    Surgery and Salivary Gland Transfer and Radiation
STARTED   49 
COMPLETED   44 [1] 
NOT COMPLETED   5 
Ineligible                3 
No protocol treatment received                2 
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients who started study treatment.

Reporting Groups
  Description
Surgery and Salivary Gland Transfer and Radiation Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.

Baseline Measures
   Surgery and Salivary Gland Transfer and Radiation 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Years]
Median (Full Range)
 56.5 
 (42 to 74) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  18.2% 
Male      36  81.8% 


  Outcome Measures

1.  Primary:   Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"   [ Time Frame: At the time of the submandibular salivary gland transfer ]

2.  Secondary:   Rate of Acute Xerostomia   [ Time Frame: From start of treatment to 90 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Salivary Scan Evaluation   [ Time Frame: From start of treatment to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Quality of Life   [ Time Frame: From registration to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Toxicity   [ Time Frame: From start of treatment to last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Disease-free Survival   [ Time Frame: From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Overall Survival   [ Time Frame: From registration to date of death or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description Subjects experiencing more than one of a given SAE (serious adverse event) 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-specfic adverse events due to the timing and sequence of treatments.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Surgery and Salivary Gland Transfer and Radiation Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.

Other Adverse Events
    Surgery and Salivary Gland Transfer and Radiation
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   38/44 (86.36%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1   
# participants affected / at risk   4/43 (9.30%) 
Lymphatics-Other * 1   
# participants affected / at risk   1/43 (2.33%) 
Ear and labyrinth disorders   
Hearing impaired * 1   
# participants affected / at risk   2/43 (4.65%) 
Hearing-Other * 1   
# participants affected / at risk   3/43 (6.98%) 
Endocrine disorders   
Hypothyroidism * 1   
# participants affected / at risk   1/43 (2.33%) 
Gastrointestinal disorders   
Constipation * 1   
# participants affected / at risk   2/43 (4.65%) 
Diarrhea NOS * 1   
# participants affected / at risk   2/43 (4.65%) 
Dry mouth † 1   
# participants affected / at risk   26/43 (60.47%) 
Dysphagia * 1   
# participants affected / at risk   6/43 (13.95%) 
Esophageal spasm * 1   
# participants affected / at risk   1/43 (2.33%) 
Esophagitis NOS * 1   
# participants affected / at risk   6/43 (13.95%) 
GI-other * 1   
# participants affected / at risk   3/43 (6.98%) 
Gastric ulcer * 1   
# participants affected / at risk   1/43 (2.33%) 
Nausea * 1   
# participants affected / at risk   10/43 (23.26%) 
Radiation mucositis * 1   
# participants affected / at risk   14/43 (32.56%) 
Salivary gland disorder NOS † 1   
# participants affected / at risk   18/43 (41.86%) 
Stomatitis * 1   
# participants affected / at risk   3/43 (6.98%) 
Vomiting NOS * 1   
# participants affected / at risk   7/43 (16.28%) 
General disorders   
Chest pain * 1   
# participants affected / at risk   1/43 (2.33%) 
Fatigue * 1   
# participants affected / at risk   17/43 (39.53%) 
Infection NOS * 1   
# participants affected / at risk   1/43 (2.33%) 
Late RT Toxicity: Esophagus † 2   
# participants affected / at risk   4/38 (10.53%) 
Late RT Toxicity: Joint † 2   
# participants affected / at risk   3/38 (7.89%) 
Late RT Toxicity: Larynx † 2   
# participants affected / at risk   6/38 (15.79%) 
Late RT Toxicity: Mucous Membrane † 2   
# participants affected / at risk   9/38 (23.68%) 
Late RT Toxicity: Other † 2   
# participants affected / at risk   10/38 (26.32%) 
Late RT Toxicity: Salivary Gland (xerostomia, taste impairme † 2   
# participants affected / at risk   22/38 (57.89%) 
Late RT Toxicity: Skin (within XRT field) † 2   
# participants affected / at risk   6/38 (15.79%) 
Late RT Toxicity: Subcutaneous Tissue (Within XRT field) † 2   
# participants affected / at risk   6/38 (15.79%) 
Pain due to radiation * 1   
# participants affected / at risk   11/43 (25.58%) 
Pain-other * 1   
# participants affected / at risk   8/43 (18.60%) 
Pyrexia * 1   
# participants affected / at risk   2/43 (4.65%) 
Rigors * 1   
# participants affected / at risk   1/43 (2.33%) 
Immune system disorders   
Allergy-Other * 1   
# participants affected / at risk   1/43 (2.33%) 
Infections and infestations   
Infection, Other * 1   
# participants affected / at risk   5/43 (11.63%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS * 1   
# participants affected / at risk   12/43 (27.91%) 
Investigations   
Blood creatinine increased * 1   
# participants affected / at risk   1/43 (2.33%) 
Leukopenia NOS * 1   
# participants affected / at risk   3/43 (6.98%) 
Weight decreased * 1   
# participants affected / at risk   12/43 (27.91%) 
Metabolism and nutrition disorders   
Anorexia * 1   
# participants affected / at risk   7/43 (16.28%) 
Blood albumin decreased * 1   
# participants affected / at risk   1/43 (2.33%) 
Blood magnesium decreased * 1   
# participants affected / at risk   1/43 (2.33%) 
Dehydration * 1   
# participants affected / at risk   5/43 (11.63%) 
Hypokalemia * 1   
# participants affected / at risk   1/43 (2.33%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other * 1   
# participants affected / at risk   5/43 (11.63%) 
Muscle weakness NOS * 1   
# participants affected / at risk   1/43 (2.33%) 
Nervous system disorders   
Depressed level of consciousness * 1   
# participants affected / at risk   1/43 (2.33%) 
Peripheral motor neuropathy * 1   
# participants affected / at risk   1/43 (2.33%) 
Peripheral sensory neuropathy * 1   
# participants affected / at risk   1/43 (2.33%) 
Taste disturbance † 1   
# participants affected / at risk   23/43 (53.49%) 
Psychiatric disorders   
Anxiety NEC * 1   
# participants affected / at risk   2/43 (4.65%) 
Insomnia NEC * 1   
# participants affected / at risk   2/43 (4.65%) 
Reproductive system and breast disorders   
Sexual/reproductive function-Other * 1   
# participants affected / at risk   1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1   
# participants affected / at risk   5/43 (11.63%) 
Dysphonia * 1   
# participants affected / at risk   2/43 (4.65%) 
Dyspnea NOS * 1   
# participants affected / at risk   5/43 (11.63%) 
Hemoptysis * 1   
# participants affected / at risk   2/43 (4.65%) 
Hypoxia * 1   
# participants affected / at risk   1/43 (2.33%) 
Pulmonary-other * 1   
# participants affected / at risk   2/43 (4.65%) 
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative NOS * 1   
# participants affected / at risk   6/43 (13.95%) 
Erythema multiforme * 1   
# participants affected / at risk   1/43 (2.33%) 
Skin discoloration * 1   
# participants affected / at risk   1/43 (2.33%) 
Skin-Other * 1   
# participants affected / at risk   2/43 (4.65%) 
Surgical and medical procedures   
Acute Surgical Complication: Facial edema †   
# participants affected / at risk   6/44 (13.64%) 
Acute Surgical Complication: Facial edema on the transfer si †   
# participants affected / at risk   6/44 (13.64%) 
Acute Surgical Complication: Gland movement out of position †   
# participants affected / at risk   1/44 (2.27%) 
Acute Surgical Complication: Neck numbness †   
# participants affected / at risk   3/44 (6.82%) 
Acute Surgical Complication: Neck numbness on the transfer s †   
# participants affected / at risk   2/44 (4.55%) 
Acute Surgical Complication: Nerve injury: hypoglossal †   
# participants affected / at risk   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: hypoglossal on th †   
# participants affected / at risk   1/44 (2.27%) 
Acute Surgical Complication: Nerve injury: lingual †   
# participants affected / at risk   1/44 (2.27%) 
Acute Surgical Complication: Other †   
# participants affected / at risk   4/44 (9.09%) 
Acute Surgical Complication: Shoulder weakness †   
# participants affected / at risk   2/44 (4.55%) 
Acute Surgical Complication: Shoulder weakness on the transf †   
# participants affected / at risk   1/44 (2.27%) 
Late Surgical Complication: Other †   
# participants affected / at risk   10/44 (22.73%) 
Late Surgical Complication: Recurrent adenitis †   
# participants affected / at risk   1/44 (2.27%) 
Late Surgical Complication: Submental fullness †   
# participants affected / at risk   8/44 (18.18%) 
Vascular disorders   
Edema NOS * 1   
# participants affected / at risk   3/43 (6.98%) 
Hemorrhage-Other * 1   
# participants affected / at risk   1/43 (2.33%) 
Lymphangiopathy NOS * 1   
# participants affected / at risk   2/43 (4.65%) 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, CTCAE (2.0)
2 Term from vocabulary, RTOG/EORTC Late Tox.



  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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)
e-mail: wseiferheld@acr.org


Publications of Results:

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 17, 2017