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Trial record 17 of 62 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


  Other 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).

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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+

Other Adverse Events
    IMRT +/- Chemotherapy
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   68/68 (100.00%) 
Blood and lymphatic system disorders   
Hematologic-Other   
# participants affected / at risk   8/68 (11.76%) 
Hemoglobin decreased   
# participants affected / at risk   51/68 (75.00%) 
Cardiac disorders   
Edema NOS   
# participants affected / at risk   13/68 (19.12%) 
Ear and labyrinth disorders   
Earache   
# participants affected / at risk   4/68 (5.88%) 
Hearing impaired   
# participants affected / at risk   33/68 (48.53%) 
Hearing-Other   
# participants affected / at risk   17/68 (25.00%) 
Late RT toxicity: Auditory/hearing: NOS † 2   
# participants affected / at risk   32/68 (47.06%) 
Otitis media serous NOS   
# participants affected / at risk   7/68 (10.29%) 
Endocrine disorders   
Hypothyroidism   
# participants affected / at risk   10/68 (14.71%) 
Gastrointestinal disorders   
Constipation   
# participants affected / at risk   14/68 (20.59%) 
Diarrhea NOS   
# participants affected / at risk   9/68 (13.24%) 
Dry mouth † 1   
# participants affected / at risk   61/68 (89.71%) 
Dysphagia   
# participants affected / at risk   24/68 (35.29%) 
Esophagitis NOS   
# participants affected / at risk   28/68 (41.18%) 
GI-other   
# participants affected / at risk   8/68 (11.76%) 
Late RT toxicity: Esophagus: NOS † 2   
# participants affected / at risk   28/68 (41.18%) 
Late RT toxicity: Larynx: NOS † 2   
# participants affected / at risk   13/68 (19.12%) 
Late RT toxicity: Mucous membrane: NOS † 2   
# participants affected / at risk   41/68 (60.29%) 
Late RT toxicity: Salivary gland: NOS † 2   
# participants affected / at risk   51/68 (75.00%) 
Nausea   
# participants affected / at risk   46/68 (67.65%) 
Radiation mucositis   
# participants affected / at risk   50/68 (73.53%) 
Salivary gland disorder NOS † 1   
# participants affected / at risk   59/68 (86.76%) 
Stomatitis   
# participants affected / at risk   15/68 (22.06%) 
Vomiting NOS   
# participants affected / at risk   31/68 (45.59%) 
General disorders   
Fatigue   
# participants affected / at risk   50/68 (73.53%) 
Late RT toxicity: Other: NOS † 2   
# participants affected / at risk   33/68 (48.53%) 
Pain due to radiation   
# participants affected / at risk   24/68 (35.29%) 
Pain-other   
# participants affected / at risk   24/68 (35.29%) 
Pyrexia   
# participants affected / at risk   10/68 (14.71%) 
Rigors   
# participants affected / at risk   5/68 (7.35%) 
Infections and infestations   
Infection NOS   
# participants affected / at risk   7/68 (10.29%) 
Injury, poisoning and procedural complications   
Dermatitis radiation NOS   
# participants affected / at risk   43/68 (63.24%) 
Late RT toxicity: Skin (within RT field): NOS † 2   
# participants affected / at risk   22/68 (32.35%) 
Late RT toxicity: Subcutaneous tissue (within RT field): NOS † 2   
# participants affected / at risk   27/68 (39.71%) 
Investigations   
Alanine aminotransferase increased   
# participants affected / at risk   13/68 (19.12%) 
Aspartate aminotransferase increased   
# participants affected / at risk   9/68 (13.24%) 
Blood alkaline phosphatase NOS increased   
# participants affected / at risk   9/68 (13.24%) 
Blood bilirubin increased   
# participants affected / at risk   6/68 (8.82%) 
Blood creatinine increased   
# participants affected / at risk   12/68 (17.65%) 
Gamma-glutamyltransferase increased   
# participants affected / at risk   5/68 (7.35%) 
Leukopenia NOS   
# participants affected / at risk   50/68 (73.53%) 
Lymphopenia   
# participants affected / at risk   16/68 (23.53%) 
Metabolic-Other   
# participants affected / at risk   7/68 (10.29%) 
Neutropenia   
# participants affected / at risk   33/68 (48.53%) 
Platelet count decreased   
# participants affected / at risk   18/68 (26.47%) 
Weight decreased   
# participants affected / at risk   40/68 (58.82%) 
Metabolism and nutrition disorders   
Anorexia   
# participants affected / at risk   18/68 (26.47%) 
Blood albumin decreased   
# participants affected / at risk   19/68 (27.94%) 
Blood magnesium decreased   
# participants affected / at risk   15/68 (22.06%) 
Dehydration   
# participants affected / at risk   19/68 (27.94%) 
Hyperglycemia NOS   
# participants affected / at risk   16/68 (23.53%) 
Hyperkalemia   
# participants affected / at risk   7/68 (10.29%) 
Hypocalcemia   
# participants affected / at risk   17/68 (25.00%) 
Hypokalemia   
# participants affected / at risk   15/68 (22.06%) 
Hyponatremia   
# participants affected / at risk   26/68 (38.24%) 
Hypophosphatemia   
# participants affected / at risk   6/68 (8.82%) 
Musculoskeletal and connective tissue disorders   
Joint, muscle, or bone-Other   
# participants affected / at risk   4/68 (5.88%) 
Late RT toxicity: Bone (incl. osteonecrosis): NOS † 2   
# participants affected / at risk   4/68 (5.88%) 
Late RT toxicity: Joint: NOS † 2   
# participants affected / at risk   13/68 (19.12%) 
Nervous system disorders   
Dizziness (exc vertigo)   
# participants affected / at risk   4/68 (5.88%) 
Headache NOS   
# participants affected / at risk   10/68 (14.71%) 
Neuralgia NOS   
# participants affected / at risk   4/68 (5.88%) 
Peripheral motor neuropathy   
# participants affected / at risk   6/68 (8.82%) 
Peripheral sensory neuropathy   
# participants affected / at risk   23/68 (33.82%) 
Taste disturbance   
# participants affected / at risk   19/68 (27.94%) 
Psychiatric disorders   
Confusion   
# participants affected / at risk   4/68 (5.88%) 
Insomnia NEC   
# participants affected / at risk   4/68 (5.88%) 
Renal and urinary disorders   
Renal/GU-Other   
# participants affected / at risk   13/68 (19.12%) 
Respiratory, thoracic and mediastinal disorders   
Cough   
# participants affected / at risk   11/68 (16.18%) 
Dysphonia   
# participants affected / at risk   5/68 (7.35%) 
Dyspnea NOS   
# participants affected / at risk   6/68 (8.82%) 
Epistaxis   
# participants affected / at risk   15/68 (22.06%) 
Hiccups   
# participants affected / at risk   5/68 (7.35%) 
Pulmonary-other   
# participants affected / at risk   4/68 (5.88%) 
Rhinitis allergic NOS   
# participants affected / at risk   5/68 (7.35%) 
Skin and subcutaneous tissue disorders   
Alopecia   
# participants affected / at risk   20/68 (29.41%) 
Dermatitis exfoliative NOS   
# participants affected / at risk   6/68 (8.82%) 
Erythema multiforme   
# participants affected / at risk   6/68 (8.82%) 
Skin discoloration   
# participants affected / at risk   9/68 (13.24%) 
Skin-Other   
# participants affected / at risk   8/68 (11.76%) 
Toxicoderma   
# participants affected / at risk   4/68 (5.88%) 
Events were collected by systematic assessment
1 Term from vocabulary, CTC (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 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