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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


  Other Adverse Events

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

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

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


Other Adverse Events
    Arm I (Placebo, Cisplatin, and Radiotherapy)   Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   8/8 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Leukopenia †     
# participants affected / at risk   1/8 (12.50%)   2/10 (20.00%) 
# events   3   9 
Lymphopenia †     
# participants affected / at risk   2/8 (25.00%)   3/10 (30.00%) 
# events   18   27 
White blood cell disorder †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Cardiac disorders     
Angina pectoris †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Ear and labyrinth disorders     
Deafness †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Ear pain †     
# participants affected / at risk   2/8 (25.00%)   0/10 (0.00%) 
# events   6   0 
Hypoacusis †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Otorrhoea †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Tinnitus †     
# participants affected / at risk   1/8 (12.50%)   3/10 (30.00%) 
# events   3   12 
Eye disorders     
Diplopia †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Gastrointestinal disorders     
Abdominal discomfort †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Constipation †     
# participants affected / at risk   5/8 (62.50%)   6/10 (60.00%) 
# events   24   30 
Diarrhoea †     
# participants affected / at risk   1/8 (12.50%)   3/10 (30.00%) 
# events   3   21 
Dry mouth †     
# participants affected / at risk   5/8 (62.50%)   5/10 (50.00%) 
# events   15   15 
Dysphagia †     
# participants affected / at risk   5/8 (62.50%)   5/10 (50.00%) 
# events   21   15 
Glossodynia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Lip disorder †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Mouth ulceration †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Nausea †     
# participants affected / at risk   5/8 (62.50%)   8/10 (80.00%) 
# events   24   27 
Odynophagia †     
# participants affected / at risk   0/8 (0.00%)   2/10 (20.00%) 
# events   0   6 
Oesophageal stenosis †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Oral pain †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Reflux gastritis †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   6 
Salivary hypersecretion †     
# participants affected / at risk   2/8 (25.00%)   0/10 (0.00%) 
# events   9   0 
Stomatitis †     
# participants affected / at risk   1/8 (12.50%)   2/10 (20.00%) 
# events   3   6 
Vomiting †     
# participants affected / at risk   3/8 (37.50%)   2/10 (20.00%) 
# events   9   6 
General disorders     
Asthenia †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Fatigue †     
# participants affected / at risk   5/8 (62.50%)   6/10 (60.00%) 
# events   21   39 
Fibrosis †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Localised oedema †     
# participants affected / at risk   0/8 (0.00%)   2/10 (20.00%) 
# events   0   6 
Mucosal inflammation †     
# participants affected / at risk   4/8 (50.00%)   6/10 (60.00%) 
# events   24   30 
Oedema peripheral †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Pain †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Pyrexia †     
# participants affected / at risk   2/8 (25.00%)   2/10 (20.00%) 
# events   6   6 
Secretion discharge †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Infections and infestations     
Infection †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Oral candidiasis †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Perianal abscess †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Injury, poisoning and procedural complications     
Radiation skin injury †     
# participants affected / at risk   4/8 (50.00%)   3/10 (30.00%) 
# events   15   9 
Investigations     
Alanine aminotransferase increased †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Aspartate aminotransferase increased †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Blood bilirubin abnormal †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   6 
Blood creatine increased †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Blood creatinine increased †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   6   0 
Blood sodium abnormal †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Haemoglobin †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Haemoglobin decreased †     
# participants affected / at risk   2/8 (25.00%)   4/10 (40.00%) 
# events   9   27 
Neutrophil count decreased †     
# participants affected / at risk   2/8 (25.00%)   1/10 (10.00%) 
# events   6   3 
Platelet count decreased †     
# participants affected / at risk   1/8 (12.50%)   2/10 (20.00%) 
# events   3   9 
Weight decreased †     
# participants affected / at risk   2/8 (25.00%)   2/10 (20.00%) 
# events   6   9 
White blood cell count decreased †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Metabolism and nutrition disorders     
Anorexia †     
# participants affected / at risk   4/8 (50.00%)   3/10 (30.00%) 
# events   18   12 
Decreased appetite †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Dehydration †     
# participants affected / at risk   1/8 (12.50%)   3/10 (30.00%) 
# events   3   9 
Hyperkalaemia †     
# participants affected / at risk   2/8 (25.00%)   0/10 (0.00%) 
# events   15   0 
Hypermagnesaemia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Hypoalbuminaemia †     
# participants affected / at risk   2/8 (25.00%)   0/10 (0.00%) 
# events   6   0 
Hypocalcaemia †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Hypokalaemia †     
# participants affected / at risk   2/8 (25.00%)   1/10 (10.00%) 
# events   6   6 
Hypomagnesaemia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   21   0 
Hyponatraemia †     
# participants affected / at risk   1/8 (12.50%)   4/10 (40.00%) 
# events   6   18 
Oral intake reduced †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Musculoskeletal and connective tissue disorders     
Arthralgia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Muscle spasms †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Musculoskeletal pain †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Neck pain †     
# participants affected / at risk   1/8 (12.50%)   2/10 (20.00%) 
# events   3   6 
Pain in extremity †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Trismus †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Nervous system disorders     
Ageusia †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Dizziness †     
# participants affected / at risk   0/8 (0.00%)   2/10 (20.00%) 
# events   0   6 
Dysarthria †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Dysgeusia †     
# participants affected / at risk   4/8 (50.00%)   6/10 (60.00%) 
# events   12   21 
Facial paresis †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Headache †     
# participants affected / at risk   2/8 (25.00%)   1/10 (10.00%) 
# events   12   3 
Peripheral sensory neuropathy †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Psychiatric disorders     
Anxiety †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Insomnia †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Renal and urinary disorders     
Urinary retention †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   6   0 
Respiratory, thoracic and mediastinal disorders     
Aspiration †     
# participants affected / at risk   0/8 (0.00%)   2/10 (20.00%) 
# events   0   6 
Cough †     
# participants affected / at risk   2/8 (25.00%)   2/10 (20.00%) 
# events   6   9 
Dysphonia †     
# participants affected / at risk   2/8 (25.00%)   2/10 (20.00%) 
# events   6   6 
Dyspnoea †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Epistaxis †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Hiccups †     
# participants affected / at risk   2/8 (25.00%)   1/10 (10.00%) 
# events   6   3 
Increased upper airway secretion †     
# participants affected / at risk   0/8 (0.00%)   5/10 (50.00%) 
# events   0   18 
Pharyngolaryngeal pain †     
# participants affected / at risk   4/8 (50.00%)   6/10 (60.00%) 
# events   18   24 
Skin and subcutaneous tissue disorders     
Drug eruption †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Dry skin †     
# participants affected / at risk   1/8 (12.50%)   2/10 (20.00%) 
# events   3   6 
Erythema †     
# participants affected / at risk   4/8 (50.00%)   7/10 (70.00%) 
# events   18   30 
Exfoliative rash †     
# participants affected / at risk   0/8 (0.00%)   1/10 (10.00%) 
# events   0   3 
Rash †     
# participants affected / at risk   1/8 (12.50%)   1/10 (10.00%) 
# events   3   3 
Rash generalised †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Vascular disorders     
Hypertension †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Orthostatic hypotension †     
# participants affected / at risk   2/8 (25.00%)   0/10 (0.00%) 
# events   6   0 
Thrombosis †     
# participants affected / at risk   1/8 (12.50%)   0/10 (0.00%) 
# events   3   0 
Events were collected by systematic assessment



  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