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Trial record 17 of 64 for:    dry mouth | NIH

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00057785
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : October 13, 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: Treatment
Conditions: Head and Neck Cancer
Oral Complications of Radiation Therapy
Radiation Toxicity
Interventions: Drug: cisplatin
Drug: fluorouracil
Radiation: Intensity modulated 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
IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Participant Flow:   Overall Study
    IMRT +/- Chemotherapy
STARTED   68 
COMPLETED   68 [1] 
NOT COMPLETED   0 
[1] Subjects with data available for 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

Reporting Groups
  Description
IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Baseline Measures
   IMRT +/- Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Median (Full Range)
 48.5 
 (18 to 73) 
Gender 
[Units: Participants]
Count of Participants
 
Female      17  25.0% 
Male      51  75.0% 


  Outcome Measures

1.  Primary:   Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered   [ Time Frame: From start of treatment to end of treatment ]

2.  Secondary:   Rate of Xerostomia at 1 Year (Grade ≥ 2)   [ Time Frame: From start of treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Rate of Locoregional Control at 2 Years   [ Time Frame: From registration to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Whole Mouth Saliva Output Relative to Pretreatment Measurements   [ Time Frame: From start of treatment to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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

6.  Secondary:   Chemotherapy Compliance   [ Time Frame: From start of treatment to end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events

Time Frame No text entered.
Additional 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 nonserious adverse events (AE).

Reporting Groups
  Description
IMRT +/- Chemotherapy Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Serious Adverse Events
    IMRT +/- Chemotherapy
Total, Serious Adverse Events   
# participants affected / at risk   55/68 (80.88%) 
Blood and lymphatic system disorders   
Febrile neutropenia   
# participants affected / at risk   3/68 (4.41%) 
Hemoglobin decreased   
# participants affected / at risk   10/68 (14.71%) 
Packed red blood cell transfusion   
# participants affected / at risk   4/68 (5.88%) 
Cardiac disorders   
Edema NOS   
# participants affected / at risk   1/68 (1.47%) 
Left ventricular failure   
# participants affected / at risk   1/68 (1.47%) 
Sinus tachycardia   
# participants affected / at risk   1/68 (1.47%) 
Supraventricular arrhythmia NOS   
# participants affected / at risk   1/68 (1.47%) 
Ventricular arrhythmia NOS   
# participants affected / at risk   1/68 (1.47%) 
Ear and labyrinth disorders   
Hearing impaired   
# participants affected / at risk   8/68 (11.76%) 
Hearing-Other   
# participants affected / at risk   3/68 (4.41%) 
Otitis externa (exc boil of meatus) NOS   
# participants affected / at risk   2/68 (2.94%) 
Endocrine disorders   
Endocrine-Other   
# participants affected / at risk   2/68 (2.94%) 
Hypothyroidism   
# participants affected / at risk   1/68 (1.47%) 
Gastrointestinal disorders   
Diarrhea NOS   
# participants affected / at risk   1/68 (1.47%) 
Dry mouth † 1   
# participants affected / at risk   3/68 (4.41%) 
Dysphagia   
# participants affected / at risk   16/68 (23.53%) 
Esophageal spasm   
# participants affected / at risk   6/68 (8.82%) 
Esophagitis NOS   
# participants affected / at risk   13/68 (19.12%) 
Nausea   
# participants affected / at risk   21/68 (30.88%) 
Radiation mucositis   
# participants affected / at risk   28/68 (41.18%) 
Salivary gland disorder NOS † 1   
# participants affected / at risk   1/68 (1.47%) 
Stomatitis   
# participants affected / at risk   6/68 (8.82%) 
Vomiting NOS   
# participants affected / at risk   19/68 (27.94%) 
General disorders   
Fatigue   
# participants affected / at risk   6/68 (8.82%) 
Pain due to radiation   
# participants affected / at risk   6/68 (8.82%) 
Pain-other   
# participants affected / at risk   6/68 (8.82%) 
Pyrexia   
# participants affected / at risk   1/68 (1.47%) 
Infections and infestations   
Implant infection   
# participants affected / at risk   1/68 (1.47%) 
Infection NOS   
# participants affected / at risk   3/68 (4.41%) 
Infection with grade 3 or 4 neutropenia   
# participants affected / at risk   4/68 (5.88%) 
Infection with unknown ANC   
# participants affected / at risk   1/68 (1.47%) 
Infection, Other   
# participants affected / at risk   2/68 (2.94%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS   
# participants affected / at risk   6/68 (8.82%) 
Investigations   
Alanine aminotransferase increased   
# participants affected / at risk   1/68 (1.47%) 
Aspartate aminotransferase increased   
# participants affected / at risk   1/68 (1.47%) 
Blood creatinine increased   
# participants affected / at risk   1/68 (1.47%) 
CD4 lymphocytes decreased   
# participants affected / at risk   1/68 (1.47%) 
Inappropriate ADH secretion   
# participants affected / at risk   1/68 (1.47%) 
Leukocytes for BMT   
# participants affected / at risk   1/68 (1.47%) 
Leukopenia NOS   
# participants affected / at risk   4/68 (5.88%) 
Lymphopenia   
# participants affected / at risk   11/68 (16.18%) 
Neutropenia   
# participants affected / at risk   20/68 (29.41%) 
Platelet count decreased   
# participants affected / at risk   4/68 (5.88%) 
Weight decreased   
# participants affected / at risk   12/68 (17.65%) 
Weight increased   
# participants affected / at risk   1/68 (1.47%) 
Metabolism and nutrition disorders   
Acidosis NOS   
# participants affected / at risk   1/68 (1.47%) 
Anorexia   
# participants affected / at risk   7/68 (10.29%) 
Blood albumin decreased   
# participants affected / at risk   2/68 (2.94%) 
Blood magnesium decreased   
# participants affected / at risk   2/68 (2.94%) 
Dehydration   
# participants affected / at risk   11/68 (16.18%) 
Hyperglycemia NOS   
# participants affected / at risk   4/68 (5.88%) 
Hyperkalemia   
# participants affected / at risk   1/68 (1.47%) 
Hypocalcemia   
# participants affected / at risk   5/68 (7.35%) 
Hypokalemia   
# participants affected / at risk   8/68 (11.76%) 
Hyponatremia   
# participants affected / at risk   12/68 (17.65%) 
Hypophosphatemia   
# participants affected / at risk   2/68 (2.94%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other   
# participants affected / at risk   1/68 (1.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain   
# participants affected / at risk   1/68 (1.47%) 
Nervous system disorders   
Headache NOS   
# participants affected / at risk   1/68 (1.47%) 
Neurologic-Other   
# participants affected / at risk   1/68 (1.47%) 
Peripheral motor neuropathy   
# participants affected / at risk   1/68 (1.47%) 
Peripheral sensory neuropathy   
# participants affected / at risk   1/68 (1.47%) 
Syncope   
# participants affected / at risk   3/68 (4.41%) 
Psychiatric disorders   
Anxiety NEC   
# participants affected / at risk   1/68 (1.47%) 
Depression NEC   
# participants affected / at risk   1/68 (1.47%) 
Hallucination NOS   
# participants affected / at risk   2/68 (2.94%) 
Renal and urinary disorders   
Renal failure NOS   
# participants affected / at risk   1/68 (1.47%) 
Renal/GU-Other   
# participants affected / at risk   2/68 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea NOS   
# participants affected / at risk   1/68 (1.47%) 
Hypoxia   
# participants affected / at risk   3/68 (4.41%) 
Pneumonitis NOS   
# participants affected / at risk   3/68 (4.41%) 
Pulmonary-other   
# participants affected / at risk   1/68 (1.47%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme   
# participants affected / at risk   1/68 (1.47%) 
Skin-Other   
# participants affected / at risk   2/68 (2.94%) 
Vascular disorders   
Hemorrhage NOS   
# participants affected / at risk   1/68 (1.47%) 
Hypotension NOS   
# participants affected / at risk   6/68 (8.82%) 
Thrombosis NOS   
# participants affected / at risk   1/68 (1.47%) 
Events were collected by systematic assessment
1 Term from vocabulary, CTC (2.0)




  Other Adverse Events


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057785     History of Changes
Other Study ID Numbers: RTOG-0225
CDR0000269314
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: October 8, 2014
Results First Posted: October 13, 2014
Last Update Posted: February 17, 2017