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Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia


Phase 2
21 Years
N/A
Not Enrolling
Both
Dysphagia, Head and Neck Cancer, Mucositis, Xerostomia

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Trial Information

Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia


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

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

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 divided into 1A or 1B.

- Arm IA: Standard of care plus standardized nutrition therapy (SNT)

- Arm IB: Standard of care plus standardized nutrition therapy plus low weight
resistance training (LWRT).

- Arm II (amifostine): Patients are further divided into 2A or 2B.

- Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each
radiation dose plus standardized nutrition therapy

- Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each
radiation dose plus standardized nutrition therapy plus low weight resistance
training

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 tandem mass spectrometry.

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Patients With Each Degree of Swallowing Dysfunction

Outcome Description:

Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment

Outcome Time Frame:

6 months after concurrent chemotherapy and radiation

Safety Issue:

No

Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC HN 0554

NCT ID:

NCT00503776

Start Date:

January 2006

Completion Date:

August 2008

Related Keywords:

  • Dysphagia
  • Head and Neck Cancer
  • Mucositis
  • Xerostomia
  • 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
  • Deglutition Disorders
  • Head and Neck Neoplasms
  • Xerostomia
  • Mucositis

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838