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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-HN-0554 | |||
| VU-VICC-IRB-051068 |
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funding became unavailable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
Secondary
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 II (amifostine): Patients are further divided into 2A or 2B.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm IA | Active Comparator | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
|
| Arm IB | Active Comparator | Patients undergo SNT and low weight resistance training (LWRT). |
|
| Arm IIA | Experimental | 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 | Experimental | Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | Patients undergo low weight resistance training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A. Murphy, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
43 patients consented, one was ineligible for a total of 42 patients on study.
This study was open to accrual from 01/01/2006 through 03/05/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm IA | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
| FG001 | Arm IB | Patients undergo SNT and low weight resistance training (LWRT). |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm IA | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
| BG001 | Arm IB | Patients undergo SNT and low weight resistance training (LWRT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | One patient (Arm 2B) did not undergo the 6-month study | Posted | Number | participants | 6 months after concurrent chemotherapy and radiation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm IA | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| accute hearing loss | Ear and labyrinth disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center | 615-343-9444 | barbara.murphy@vanderbilt.edu |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D006258 | Head and Neck Neoplasms |
| D052016 | Mucositis |
| D014987 | Xerostomia |
| D011832 | Radiation Injuries |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D004999 | Amifostine |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| amifostine trihydrate | Drug | Given subcutaneously |
|
|
| therapeutic dietary intervention | Procedure | Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. |
|
| 6 months after concurrent chemotherapy and radiation |
| 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 |
| 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 |
| 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 |
| Physician Decision |
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergo SNT and low-weight resistance training (LWRT).
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2) | Posted | Mean | Standard Deviation | mL per minute | 6 months after concurrent chemotherapy and radiation |
|
|
|
| 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). | Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2). | Posted | Number | participants | 6 months after concurrent chemotherapy and radiation |
|
|
|
| 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. | Due to loss of funding, sufficient data for analysis was not collected. | Posted | at baseline, at 1 month, 3 months and 6 months post-chemoradiation |
|
|
| 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. | Due to loss of funding, sufficient data for analysis was not collected. | Posted | at baseline, at 1 month, 3 months and 6 months post-chemoradiation |
|
|
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Arm IB | Patients undergo SNT and low weight resistance training (LWRT). | 0 | 12 | 12 | 12 |
| EG002 | 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. | 2 | 12 | 10 | 12 |
| EG003 | 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. | 4 | 9 | 8 | 9 |
| Diarrhea | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| mucositis/stomatitis-oral cavity | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Muscle weakness - lower extremity | Skin and subcutaneous tissue disorders |
|
| Pain - abdomen NOS | Gastrointestinal disorders |
|
| pain - larynx | General disorders |
|
| pain - oral cavity | Gastrointestinal disorders |
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| pain - NOS | General disorders |
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| pain - rectal | Gastrointestinal disorders |
|
| Fever-in absence of neutropenia | General disorders |
|
| Rigor, chills | General disorders |
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| rash/desquamation | Skin and subcutaneous tissue disorders |
|
| weight loss | Investigations |
|
| vomiting | Gastrointestinal disorders |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils-blood | Infections and infestations |
|
| edema limb | General disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| difficulty chewing | Gastrointestinal disorders |
|
| dysphagia | Gastrointestinal disorders |
|
| mucositis | Gastrointestinal disorders |
|
| nausea | Gastrointestinal disorders |
|
| vomiting | Gastrointestinal disorders |
|
| dry mouth | Gastrointestinal disorders |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005759 | Gastroenteritis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D014947 | Wounds and Injuries |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| Stimulated |
|
| No. of patients with grade 1, mild mucositis |
|
| No of patients with grade 2, moderate mucositis |
|
| No of patients with grade 3, severe mucositis |
|
| No. of patients with grade 4, disabling mucositis |
|
| No. of patients with grade 5 mucositis, death |
|