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

August 8, 2014 updated by: Roswell Park Cancer Institute

Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Other: placebo
Given PO
Other Names:
  • PLCB
Experimental: 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.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Dietary supplement: selenomethionine
Given PO

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Complete Response Rate
Time Frame: Up to 5 years post-treatment
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)
Time Frame: At 1 year
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
Time Frame: Up to 5 years post-treatment
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
Time Frame: Up to 1 year post-treatment
Up to 1 year post-treatment
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Time Frame: Up to 5 years post-treatment
Will be compared as difference in proportions with 95% confidence intervals.
Up to 5 years post-treatment
CRT Dose Delivery
Time Frame: Up to 8 weeks
This characteristic will be included in Cox models.
Up to 8 weeks
Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
Time Frame: Up to 3 months post-treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 107807
  • NCI-2009-01503 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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