Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Condition: Dysphagia; Head and Neck Cancer; Mucositis; Xerostomia
MeSH terms: Deglutition Disorders; Mucositis; Xerostomia
Intervention: exercise intervention; amifostine trihydrate; therapeutic dietary intervention
Intervention description: Patients undergo low weight resistance training.; Given subcutaneously; Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Intervention MeSH terms: Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: xerostomia; mucositis; dysphagia; radiation toxicity; chemotherapeutic agent toxicity; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III verrucous carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV verrucous carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; salivary gland squamous cell carcinoma; stage III salivary gland cancer; stage IV salivary gland cancer; recurrent salivary gland cancer

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.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age greater than 21

          -  Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity
             or salivary glands

          -  No prior history of active cancer within three years other than non-melanoma skin
             cancer, early stage prostate or early stage cervical cancer

          -  controlled co-morbid disease

          -  ECOG PS of 0-3

          -  Plan for definitive or post-operative CCR within 4 weeks

          -  Written informed consent

          -  Working telephone

          -  May have received prior induction chemotherapy

          -  Agree to use only study supplied liquid nutrition supplements or dietary supplements,
             for per os or feeding tube intake

        Exclusion Criteria

          -  Diagnosed HIV or AIDS

          -  History of ETOH or drug abuse within 3 months

          -  Pregnant or lactating

          -  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) medication.

          -  Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or
             greater; b) blood pressure > 160/95; c) uncontrolled pain

          -  Does not have working telephone.