Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Supportive care, Treatment	Closed	Over 21	NCI, Other	CDR0000558549 VU-VICC-HN-0554, VU-VICC-IRB-051068, NCT00503776

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.

PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

Further Study Information

OBJECTIVES:

Primary

• To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine as measured using the modified barium swallow score with the Functional Communication Measure.

• To assess the ability to consume foods adequate to meet nutritional needs, particularly the ability to swallow solid foods and the continued need for liquid oral or enteral supplements as measured by 24-hour dietary recalls.

Secondary

• To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.

• To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.

• To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status as measured by appetite and hunger; serum biomarkers of nutritional and physical status; anthropometry; body composition including percentage of lean body mass and body fat mass; muscle strength and endurance; physical activity level; performance; functionality; and fatigue.

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.

Patients are randomized to 1 of 2 treatment arms.

• Arm I (standard of care): Patients are further randomized to 1 of 2 treatment arms.

• Arm IA: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

• Arm IB: Patients undergo SNT and low weight resistance training (LWRT).

• Arm II (amifostine): Patients are further randomized to 1 of 2 treatment arms.

• Arm IIA: Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT as in arm IA.

• Arm IIB: Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.

Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandom mass spectrometry.

After completion of study treatment, patients are followed at 1, 3, and 6 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Biopsy proven stage III or IV squamous cell carcinoma of the larynx, pharynx, oral cavity, or salivary glands

• Planning to undergo definitive or postoperative concurrent chemoradiation within the next 4 weeks

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status of 0-2

• Agrees to use only study supplied liquid nutrition supplements or dietary supplements for per os or feeding tube intake

Exclusion criteria:

• Diagnosed HIV or AIDS

• Recent history of alcohol or drug abuse

• Pregnant or lactating

• History of active cancer within the past 3 years other than non-melanoma skin cancer, early stage prostate cancer, or early stage cervical cancer

• Uncontrolled comorbid disease defined as:

• Class III or greater severe cardiac disease

• Blood pressure > 160/95 mm Hg

• Uncontrolled pain

• Does not have a working telephone

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• May have received prior induction chemotherapy

Exclusion criteria:

• On steroid medication or prescribed NSAIDs

• Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)

• On orexigenic (appetite stimulant) medications

Trial Contact Information

Trial Lead Organizations/Sponsors

Vanderbilt-Ingram Cancer Center

Barbara A. Murphy

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00503776
Information obtained from ClinicalTrials.gov on October 25, 2009

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