Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
- Conditions
- DysphagiaHead and Neck CancerMucositisXerostomia
- Interventions
- Behavioral: exercise interventionProcedure: therapeutic dietary intervention
- Registration Number
- NCT00503776
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm IB therapeutic dietary intervention Patients undergo SNT and low weight resistance training (LWRT). Arm IA therapeutic dietary intervention Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. Arm IB exercise intervention Patients undergo SNT and low weight resistance training (LWRT). Arm IIA amifostine trihydrate 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. Arm IIA therapeutic dietary intervention 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. Arm IIB exercise intervention Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. Arm IIB amifostine trihydrate Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. Arm IIB therapeutic dietary intervention Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
- Primary Outcome Measures
Name Time Method Number of Patients With Each Degree of Swallowing Dysfunction 6 months after concurrent chemotherapy and radiation 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
- Secondary Outcome Measures
Name Time Method Stimulated and Unstimulated Salivary Production 6 months after concurrent chemotherapy and radiation 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.
Changes in the Amount and Texture of Food Consumed at baseline, at 1 month, 3 months and 6 months post-chemoradiation 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.
Changes in the Frequency and Types of Dietary Intakes at baseline, at 1 month, 3 months and 6 months post-chemoradiation 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.
Number of Patients With Oral Mucositis by Grade 6 months after concurrent chemotherapy and radiation 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).
Trial Locations
- Locations (1)
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States