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

Primary Purpose

Dysphagia, Head and Neck Cancer, Mucositis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

exercise intervention

amifostine trihydrate

therapeutic dietary intervention

About this trial

This is an interventional supportive care trial for Dysphagia focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm IA

Arm IB

Arm IIA

Arm IIB

Arm Description

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients undergo SNT and low weight resistance training (LWRT).

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.

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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).

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.

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.

Full Information

NCT ID

NCT00503776

First Posted

July 17, 2007

Last Updated

May 28, 2017

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00503776

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

funding became unavailable

Study Start Date

January 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm IA

Arm Type

Active Comparator

Arm Description

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Arm Title

Arm IB

Arm Type

Active Comparator

Arm Description

Patients undergo SNT and low weight resistance training (LWRT).

Arm Title

Arm IIA

Arm Type

Experimental

Arm Description

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 Title

Arm IIB

Arm Type

Experimental

Arm Description

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

Intervention Type

Behavioral

Intervention Name(s)

exercise intervention

Intervention Description

Patients undergo low weight resistance training.

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

Other Intervention Name(s)

Ethyol

Intervention Description

Given subcutaneously

Intervention Type

Procedure

Intervention Name(s)

therapeutic dietary intervention

Intervention Description

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Primary Outcome Measure Information:

Title

Number of Patients With Each Degree of Swallowing Dysfunction

Description

Time Frame

6 months after concurrent chemotherapy and radiation

Secondary Outcome Measure Information:

Title

Stimulated and Unstimulated Salivary Production

Description

Time Frame

6 months after concurrent chemotherapy and radiation

Title

Number of Patients With Oral Mucositis by Grade

Description

Time Frame

6 months after concurrent chemotherapy and radiation

Title

Changes in the Amount and Texture of Food Consumed

Description

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.

Time Frame

at baseline, at 1 month, 3 months and 6 months post-chemoradiation

Title

Changes in the Frequency and Types of Dietary Intakes

Description

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.

Time Frame

at baseline, at 1 month, 3 months and 6 months post-chemoradiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara A. Murphy, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

12. IPD Sharing Statement

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

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