Clinical trial NCT00503776
Conditions: Dysphagia Head and Neck Cancer Mucositis Xerostomia
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
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2006-01-01; Completion date: 2008-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. arm 2: Patients undergo SNT and low weight resistance training (LWRT). arm 3: 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 4: Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Interventions: intervention 1: exercise intervention intervention 2: amifostine trihydrate intervention 3: therapeutic dietary intervention
Intervention descriptions: intervention 1: Patients undergo low weight resistance training. intervention 2: Given subcutaneously intervention 3: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Protocol documents: