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NCT01682031 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2014-08-22

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence of >= Grade 3 Mucositis

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outcome · POSTED

Tumor Complete Response Rate

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outcome · POSTED

Relapse-free Survival (RFS)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Quality of Life

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outcome · POSTED

Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia

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outcome · POSTED

CRT Dose Delivery

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outcome · POSTED

Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses * Stage III, IVa or IVb disease * No prior definitive surgery for present diagnosis * Appropriate candidate for concurrent cisplatin and radiation as definitive treatment; patients who receive induction chemotherapy as part of a definitive treatment program that will include concurrent CRT are eligible for this study * Hemoglobin \>= 10 g/dL (100 g/l) * Absolute neutrophil count \>= 2,000 cells/mm\^3 (2 x 10\^9/l) * Platelets \>= 100,000 cells/mm\^3 (100 x 10\^9/l) * Serum creatinine =\< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance \>= 50 ml/min using the Cockcroft-Gault formula * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Able to give written informed consent * Be willing and able to comply with study procedures Exclusion Criteria: * Non-regional metastatic disease (stage IVc) * Previous malignancy within the last 5 years except for adequately treated basal or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia * Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would compromise delivery of a radical dose to the HNSCC * Known to be positive for hepatitis C or human immunodeficiency virus (HIV) * Unable to tolerate oral medication (unless a feeding tube is in place) * History of hypersensitivity to platinum drugs * Symptomatic peripheral neuropathy \>= National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade II * Pregnant, lactating or unwilling to use adequate contraception * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Planned use of amifostine for prophylaxis against radiation-induced xerostomia * Patients taking selenium supplements in excess of 100 ug/day * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during the study
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Other: placebo
    2. Drug: cisplatin
    3. Radiation: radiation therapy
    4. Procedure: quality-of-life assessment
    label
    Arm I (placebo, cisplatin, and radiotherapy)
    type
    PLACEBO_COMPARATOR
  2. description
    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.
    intervention Names
    1. Dietary Supplement: selenomethionine
    2. Drug: cisplatin
    3. Radiation: radiation therapy
    4. Procedure: quality-of-life assessment
    label
    Arm II (selenomethionine, cisplatin, and radiotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (selenomethionine, cisplatin, and radiotherapy)
    description
    Given PO
    name
    selenomethionine
    type
    DIETARY_SUPPLEMENT
  2. arm Group Labels
    1. Arm I (placebo, cisplatin, and radiotherapy)
    description
    Given PO
    name
    placebo
    other Names
    1. PLCB
    type
    OTHER
  3. arm Group Labels
    1. Arm I (placebo, cisplatin, and radiotherapy)
    2. Arm II (selenomethionine, cisplatin, and radiotherapy)
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    type
    DRUG
  4. arm Group Labels
    1. Arm I (placebo, cisplatin, and radiotherapy)
    2. Arm II (selenomethionine, cisplatin, and radiotherapy)
    description
    Undergo radiotherapy
    name
    radiation therapy
    other Names
    1. irradiation
    2. radiotherapy
    3. therapy, radiation
    type
    RADIATION
  5. arm Group Labels
    1. Arm I (placebo, cisplatin, and radiotherapy)
    2. Arm II (selenomethionine, cisplatin, and radiotherapy)
    description
    Ancillary studies
    name
    quality-of-life assessment
    other Names
    1. quality of life assessment
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Will be compared as difference in proportions with 95% confidence intervals.
    measure
    Incidence of >= Grade 3 Mucositis
    time Frame
    Up to 5 years
secondary Outcomes
  1. 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).
    measure
    Tumor Complete Response Rate
    time Frame
    Up to 5 years post-treatment
  2. 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.
    measure
    Relapse-free Survival (RFS)
    time Frame
    At 1 year
  3. 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.
    measure
    Overall Survival
    time Frame
    Up to 5 years post-treatment
  4. measure
    Quality of Life
    time Frame
    Up to 1 year post-treatment
  5. description
    Will be compared as difference in proportions with 95% confidence intervals.
    measure
    Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
    time Frame
    Up to 5 years post-treatment
  6. description
    This characteristic will be included in Cox models.
    measure
    CRT Dose Delivery
    time Frame
    Up to 8 weeks
  7. 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.
    measure
    Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
    time Frame
    Up to 3 months post-treatment
Full study description
brief Summary
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
detailed Description
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice