Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Barbara Murphy, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00503776

Purpose

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.

Condition	Intervention	Phase
Dysphagia Head and Neck Cancer Mucositis Xerostomia	Behavioral: exercise intervention Drug: amifostine trihydrate Procedure: therapeutic dietary intervention	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dry Mouth Exercise and Physical Fitness Head and Neck Cancer Swallowing Disorders

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

Number of Patients With Each Degree of Swallowing Dysfunction as Measured by the Modified Barium Swallow Score [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: No ]
Grade of swallowing dysfunction: 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

Secondary Outcome Measures:

Stimulated and Unstimulated Salivary Production [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: No ]
Changes in the Amounts and Textures of Food Consumed as Measured by 24-hour Dietary Recalls [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: No ]
Mucositis as Measured by CTC 3.0 [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: Yes ]
Biochemical and Inflammatory Markers Including C-reactive Protein and Cytokines and a Marker of Whole Body Oxidative Stress [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: No ]
Changes in the Frequency and Types of Dietary Intakes as Measured by 24-hour Dietary Recalls [ Time Frame: 6 months after concurrent chemothearpy and radiation ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	January 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm IA Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.	Procedure: therapeutic dietary intervention Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Other Name: therapeutic dietary intervention
Active Comparator: Arm IB Patients undergo SNT and low weight resistance training (LWRT).	Behavioral: exercise intervention Patients undergo low weight resistance training. Other Name: exercise intervention Procedure: therapeutic dietary intervention Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Other Name: therapeutic dietary intervention
Experimental: Arm IIA Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.	Drug: amifostine trihydrate Given subcutaneously Other Name: Ethyol Procedure: therapeutic dietary intervention Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Other Name: therapeutic dietary intervention
Experimental: 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.	Behavioral: exercise intervention Patients undergo low weight resistance training. Other Name: exercise intervention Drug: amifostine trihydrate Given subcutaneously Other Name: Ethyol Procedure: therapeutic dietary intervention Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Other Name: therapeutic dietary intervention

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503776

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara A. Murphy, MD

Vanderbilt-Ingram Cancer Center

More Information

No publications provided

Responsible Party:	Barbara Murphy, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00503776 History of Changes
Other Study ID Numbers:	VICC HN 0554, VU-VICC-HN-0554, VU-VICC-IRB-051068
Study First Received:	July 17, 2007
Results First Received:	November 3, 2011
Last Updated:	November 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:

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

Additional relevant MeSH terms:

Deglutition Disorders
Head and Neck Neoplasms
Xerostomia
Mucositis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Neoplasms by Site

Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012