ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 64 for:    dry mouth | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00503776
Recruitment Status : Terminated (funding became unavailable)
First Posted : July 19, 2007
Results First Posted : December 8, 2011
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

July 17, 2007
July 19, 2007
November 3, 2011
December 8, 2011
June 20, 2017
January 2006
August 2008   (Final data collection date for primary outcome measure)
Number of Patients With Each Degree of Swallowing Dysfunction [ Time Frame: 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
Swallowing dysfunction as measured by the modified barium swallow score, dental history and extractions, and 24-hour dietary recalls
Complete list of historical versions of study NCT00503776 on ClinicalTrials.gov Archive Site
  • Stimulated and Unstimulated Salivary Production [ Time Frame: 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.
  • Number of Patients With Oral Mucositis by Grade [ Time Frame: 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).
  • Changes in the Amount and Texture of Food Consumed [ Time Frame: 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 [ Time Frame: 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.
  • Stimulated and Unstimulated Salivary Production
  • Changes in the Amounts and Textures of Food Consumed as Measured by 24-hour Dietary Recalls
  • Mucositis as Measured by CTC 3.0
  • Biochemical and Inflammatory Markers Including C-reactive Protein and Cytokines and a Marker of Whole Body Oxidative Stress
  • Changes in the Frequency and Types of Dietary Intakes as Measured by 24-hour Dietary Recalls
Not Provided
Not Provided
 
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Dysphagia
  • Head and Neck Cancer
  • Mucositis
  • Xerostomia
  • Behavioral: exercise intervention
    Patients undergo low weight resistance training.
  • 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.
  • Active Comparator: Arm IA
    Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
    Intervention: Procedure: therapeutic dietary intervention
  • Active Comparator: Arm IB
    Patients undergo SNT and low weight resistance training (LWRT).
    Interventions:
    • Behavioral: exercise intervention
    • Procedure: 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.
    Interventions:
    • Drug: amifostine trihydrate
    • Procedure: 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.
    Interventions:
    • Behavioral: exercise intervention
    • Drug: amifostine trihydrate
    • Procedure: therapeutic dietary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
60
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00503776
VICC HN 0554
VU-VICC-HN-0554
VU-VICC-IRB-051068
Yes
Not Provided
Not Provided
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP