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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 ]

Measure Type Primary
Measure Title Incidence of >= Grade 3 Mucositis
Measure Description Will be compared as difference in proportions with 95% confidence intervals.
Time Frame Up to 5 years  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Incidence of >= Grade 3 Mucositis       

No statistical analysis provided for Incidence of >= Grade 3 Mucositis



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

Measure Type Secondary
Measure Title Tumor Complete Response Rate
Measure Description Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame Up to 5 years post-treatment  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Tumor Complete Response Rate       

No statistical analysis provided for Tumor Complete Response Rate



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

Measure Type Secondary
Measure Title Relapse-free Survival (RFS)
Measure Description Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.
Time Frame At 1 year  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Relapse-free Survival (RFS)       

No statistical analysis provided for Relapse-free Survival (RFS)



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

Measure Type Secondary
Measure Title Overall Survival
Measure Description Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.
Time Frame Up to 5 years post-treatment  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Overall Survival       

No statistical analysis provided for Overall Survival



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

Measure Type Secondary
Measure Title Quality of Life
Measure Description No text entered.
Time Frame Up to 1 year post-treatment  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Quality of Life       

No statistical analysis provided for Quality of Life



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

Measure Type Secondary
Measure Title Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Measure Description Will be compared as difference in proportions with 95% confidence intervals.
Time Frame Up to 5 years post-treatment  

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 treated and eligible patients

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   8   10 
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia 
[Units: Number of xerostomia events]
 1   0 

No statistical analysis provided for Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia



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

Measure Type Secondary
Measure Title CRT Dose Delivery
Measure Description This characteristic will be included in Cox models.
Time Frame Up to 8 weeks  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
CRT Dose Delivery       

No statistical analysis provided for CRT Dose Delivery



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

Measure Type Secondary
Measure Title Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
Measure Description Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.
Time Frame Up to 3 months post-treatment  

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

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


Measured Values
   Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy) 
Participants Analyzed   0   0 
Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)       

No statistical analysis provided for Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)




  Serious Adverse Events


  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