| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01503 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
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Due to a lack of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
PRIMARY OBJECTIVES:
I. To assess whether SLM reduces the incidence of grade 3 or 4 mucositis in head and neck squamous cell carcinoma (HNSCC) patients treated with concurrent chemoradiation (CRT) over 7 weeks.
SECONDARY OBJECTIVES:
I. To assess the impact of SLM on tumor complete response rate, relapse-free survival, overall survival and quality of life.
II. To assess whether SLM reduces the incidence and severity of treatment-related toxicities including xerostomia, renal impairment and myelosuppression.
III. To assess whether SLM improves chemoradiation dose delivery. IV. To determine safety of SLM at this dose. V. In New Zealand (NZ) patients only, to assess the impact of SLM on plasma free cisplatin and plasma selenium pharmacokinetics (PK) and on pharmacodynamic (PD) markers of biological activity of selenium.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive placebo orally (PO) twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin intravenously (IV) over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
ARM II: 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.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (placebo, cisplatin, and radiotherapy) | Placebo Comparator | 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. |
|
| Arm II (selenomethionine, cisplatin, and radiotherapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenomethionine | Dietary Supplement | Given PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of >= Grade 3 Mucositis | Will be compared as difference in proportions with 95% confidence intervals. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Complete Response Rate | 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). | Up to 5 years post-treatment |
| Relapse-free Survival (RFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States | ||
| Waikato Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Other |
Given PO |
|
|
| cisplatin | Drug | Given IV |
|
|
| radiation therapy | Radiation | Undergo radiotherapy |
|
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
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. |
| At 1 year |
| Overall Survival | 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. | Up to 5 years post-treatment |
| Quality of Life | Up to 1 year post-treatment |
| Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia | Will be compared as difference in proportions with 95% confidence intervals. | Up to 5 years post-treatment |
| CRT Dose Delivery | This characteristic will be included in Cox models. | Up to 8 weeks |
| Plasma Cisplatin and Selenium PK and PD Markers (NZ Only) | 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. | Up to 3 months post-treatment |
| Hamilton |
| 3204 |
| New Zealand |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of >= Grade 3 Mucositis | Will be compared as difference in proportions with 95% confidence intervals. | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 5 years |
|
| ||||||||||||||||||||||
| Secondary | Tumor Complete Response Rate | 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). | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 5 years post-treatment |
|
| ||||||||||||||||||||||
| Secondary | Relapse-free Survival (RFS) | 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. | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | At 1 year |
|
| ||||||||||||||||||||||
| Secondary | Overall Survival | 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. | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 5 years post-treatment |
|
| ||||||||||||||||||||||
| Secondary | Quality of Life | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 1 year post-treatment |
|
| |||||||||||||||||||||||
| Secondary | Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia | Will be compared as difference in proportions with 95% confidence intervals. | All treated and eligible patients | Posted | Number | number of xerostomia events | Up to 5 years post-treatment |
|
| ||||||||||||||||||||
| Secondary | CRT Dose Delivery | This characteristic will be included in Cox models. | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 8 weeks |
|
| ||||||||||||||||||||||
| Secondary | Plasma Cisplatin and Selenium PK and PD Markers (NZ Only) | 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. | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | Up to 3 months post-treatment |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 4 | 8 | 8 | 8 | ||
| EG001 | 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 | 2 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Blood creatine increased | Investigations | Systematic Assessment |
| ||
| Blood sodium abnormal | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| White blood cell disorder | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Deafness | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypoacusis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Otorrhoea | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal stenosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Reflux gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Salivary hypersecretion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fibrosis | General disorders | Systematic Assessment |
| ||
| Localised oedema | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Secretion discharge | General disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Perianal abscess | Infections and infestations | Systematic Assessment |
| ||
| Radiation skin injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin abnormal | Investigations | Systematic Assessment |
| ||
| Blood creatine increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood sodium abnormal | Investigations | Systematic Assessment |
| ||
| Haemoglobin | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Oral intake reduced | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ageusia | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Facial paresis | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Exfoliative rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
|
Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D052016 | Mucositis |
| D011832 | Radiation Injuries |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D012466 | Salivary Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012645 | Selenomethionine |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D016566 | Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|