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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00503776
• Other study ID #: VICC HN 0554
• Secondary ID: VU-VICC-HN-0554V
• Status: Terminated
• Phase: Phase 2
• First received: July 17, 2007
• Last updated: October 23, 2012
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• exercise intervention
Patients undergo low weight resistance training.

Drug:
• amifostine trihydrate
Given subcutaneously

Procedure:
• therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Each Degree of Swallowing Dysfunction	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	6 months after concurrent chemotherapy and radiation	No
Secondary	Stimulated and Unstimulated Salivary Production	Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.	6 months after concurrent chemotherapy and radiation	No
Secondary	Number of Patients With Oral Mucositis by Grade	Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).	6 months after concurrent chemotherapy and radiation	Yes
Secondary	Changes in the Amount and Texture of Food Consumed	Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.	at baseline, at 1 month, 3 months and 6 months post-chemoradiation	No
Secondary	Changes in the Frequency and Types of Dietary Intakes	Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.	at baseline, at 1 month, 3 months and 6 months post-chemoradiation	No