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Trial record 36 of 62 for:    dry mouth | NIH

Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy

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ClinicalTrials.gov Identifier: NCT01682031
Recruitment Status : Terminated (Due to a lack of funding)
First Posted : September 10, 2012
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Supportive Care
Conditions: Chemotherapeutic Agent Toxicity
Mucositis
Radiation Toxicity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Xerostomia
Interventions: Dietary Supplement: selenomethionine
Other: placebo
Drug: cisplatin
Radiation: radiation therapy
Procedure: quality-of-life assessment

  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
Arm I (Placebo, Cisplatin, and Radiotherapy)

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies


Participant Flow:   Overall Study
    Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
STARTED   8   10 
COMPLETED   7   5 
NOT COMPLETED   1   5 
Withdrawal by Subject                0                1 
Adverse Event                0                2 
MRI results indicate increased nodul                0                1 
Patient could not swallow tablets                1                0 
Patient stopped selenium on his own                0                1 



  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.
No text entered.

Reporting Groups
  Description
Arm I (Placebo, Cisplatin, and Radiotherapy)

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Total Total of all reporting groups

Baseline Measures
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   10   18 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (6.6)   57.4  (8.2)   57.1  (7.3) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   9   16 
>=65 years   1   1   2 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   8   10   18 


  Outcome Measures

1.  Primary:   Incidence of >= Grade 3 Mucositis   [ Time Frame: Up to 5 years ]

2.  Secondary:   Tumor Complete Response Rate   [ Time Frame: Up to 5 years post-treatment ]

3.  Secondary:   Relapse-free Survival (RFS)   [ Time Frame: At 1 year ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years post-treatment ]

5.  Secondary:   Quality of Life   [ Time Frame: Up to 1 year post-treatment ]

6.  Secondary:   Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia   [ Time Frame: Up to 5 years post-treatment ]

7.  Secondary:   CRT Dose Delivery   [ Time Frame: Up to 8 weeks ]

8.  Secondary:   Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)   [ Time Frame: Up to 3 months post-treatment ]


  Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Arm I (Placebo, Cisplatin, and Radiotherapy)

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

placebo: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies

Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.

selenomethionine: Given PO

cisplatin: Given IV

radiation therapy: Undergo radiotherapy

quality-of-life assessment: Ancillary studies


Serious Adverse Events
    Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Total, Serious Adverse Events     
# participants affected / at risk   4/8 (50.00%)   2/10 (20.00%) 
Blood and lymphatic system disorders     
Leukopenia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Cardiac disorders     
Ventricular tachycardia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Gastrointestinal disorders     
Abdominal pain †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Stomatitis †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
General disorders     
Mucosal inflammation †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Pyrexia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Investigations     
Blood creatine increased †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Blood sodium abnormal †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Haemoglobin decreased †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Neutrophil count decreased †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Metabolism and nutrition disorders     
Dehydration †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Nervous system disorders     
Cerebrovascular accident †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Dizziness †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   6 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   6   0 
Vascular disorders     
Orthostatic hypotension †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Events were collected by systematic assessment




  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
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01682031     History of Changes
Obsolete Identifiers: NCT00935038
Other Study ID Numbers: I 107807
NCI-2009-01503 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 5, 2012
First Posted: September 10, 2012
Results First Submitted: June 26, 2014
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014