NCT00503776 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2017-06-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Each Degree of Swallowing Dysfunction

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outcome · POSTED

Stimulated and Unstimulated Salivary Production

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outcome · POSTED

Number of Patients With Oral Mucositis by Grade

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outcome · POSTED

Changes in the Amount and Texture of Food Consumed

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outcome · POSTED

Changes in the Frequency and Types of Dietary Intakes

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
intervention Names
Procedure: therapeutic dietary intervention
label
Arm IA
type
ACTIVE_COMPARATOR
description
Patients undergo SNT and low weight resistance training (LWRT).
intervention Names
Behavioral: exercise intervention
Procedure: therapeutic dietary intervention
label
Arm IB
type
ACTIVE_COMPARATOR
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.
intervention Names
Drug: amifostine trihydrate
Procedure: therapeutic dietary intervention
label
Arm IIA
type
EXPERIMENTAL
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 Names
Behavioral: exercise intervention
Drug: amifostine trihydrate
Procedure: therapeutic dietary intervention
label
Arm IIB
type
EXPERIMENTAL

interventions

arm Group Labels
Arm IB
Arm IIB
description
Patients undergo low weight resistance training.
name
exercise intervention
type
BEHAVIORAL
arm Group Labels
Arm IIA
Arm IIB
description
Given subcutaneously
name
amifostine trihydrate
other Names
Ethyol
type
DRUG
arm Group Labels
Arm IA
Arm IB
Arm IIA
Arm IIB
description
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
name
therapeutic dietary intervention
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 41
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
Number of Patients With Each Degree of Swallowing Dysfunction
time Frame
6 months after concurrent chemotherapy and radiation

secondary Outcomes

description
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.
measure
Stimulated and Unstimulated Salivary Production
time Frame
6 months after concurrent chemotherapy and radiation
description
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).
measure
Number of Patients With Oral Mucositis by Grade
time Frame
6 months after concurrent chemotherapy and radiation
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.
measure
Changes in the Amount and Texture of Food Consumed
time Frame
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
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.
measure
Changes in the Frequency and Types of Dietary Intakes
time Frame
at baseline, at 1 month, 3 months and 6 months post-chemoradiation

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice