Trial Outcomes & Findings for Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia (NCT NCT00503776)
NCT ID: NCT00503776
Last Updated: 2017-06-20
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 months after concurrent chemotherapy and radiation
Results posted on
2017-06-20
Participant Flow
This study was open to accrual from 01/01/2006 through 03/05/2008.
43 patients consented, one was ineligible for a total of 42 patients on study.
Participant milestones
| Measure |
Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
12
|
10
|
|
Overall Study
COMPLETED
|
7
|
12
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Baseline characteristics by cohort
| Measure |
Arm IA
n=8 Participants
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=12 Participants
Patients undergo SNT and low weight resistance training (LWRT).
|
Arm IIA
n=12 Participants
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
n=10 Participants
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 1 • n=99 Participants
|
55 years
STANDARD_DEVIATION 1 • n=107 Participants
|
54 years
STANDARD_DEVIATION 1 • n=206 Participants
|
55 years
STANDARD_DEVIATION 1 • n=7 Participants
|
54 years
STANDARD_DEVIATION 1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
10 participants
n=7 Participants
|
42 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 months after concurrent chemotherapy and radiationPopulation: One patient (Arm 2B) did not undergo the 6-month study
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
Outcome measures
| Measure |
Arm IA
n=8 Participants
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=12 Participants
Patients undergo SNT and low-weight resistance training (LWRT).
|
Arm IIA
n=12 Participants
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
n=9 Participants
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
|---|---|---|---|---|
|
Number of Patients With Each Degree of Swallowing Dysfunction
No. of patients with dysphagia grade 0
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Patients With Each Degree of Swallowing Dysfunction
No. of patients with dysphagia grade 1
|
1 participants
|
5 participants
|
4 participants
|
4 participants
|
|
Number of Patients With Each Degree of Swallowing Dysfunction
No. of patients with dysphagia grade 2
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Patients With Each Degree of Swallowing Dysfunction
No. of patients with dysphagia grade 3
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Patients With Each Degree of Swallowing Dysfunction
No. of patients with dysphagia grade 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Each Degree of Swallowing Dysfunction
Not Accessible
|
1 participants
|
4 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months after concurrent chemotherapy and radiationPopulation: 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)
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.
Outcome measures
| Measure |
Arm IA
n=7 Participants
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=8 Participants
Patients undergo SNT and low-weight resistance training (LWRT).
|
Arm IIA
n=9 Participants
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
n=8 Participants
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
|---|---|---|---|---|
|
Stimulated and Unstimulated Salivary Production
Unstimulated
|
0.64 mL per minute
Standard Deviation 0.37
|
1.70 mL per minute
Standard Deviation 1.44
|
1.38 mL per minute
Standard Deviation 1.90
|
0.68 mL per minute
Standard Deviation 0.32
|
|
Stimulated and Unstimulated Salivary Production
Stimulated
|
0.72 mL per minute
Standard Deviation 1.85
|
5.04 mL per minute
Standard Deviation 3.16
|
5.25 mL per minute
Standard Deviation 3.39
|
0.94 mL per minute
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 6 months after concurrent chemotherapy and radiationPopulation: 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).
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).
Outcome measures
| Measure |
Arm IA
n=7 Participants
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=8 Participants
Patients undergo SNT and low-weight resistance training (LWRT).
|
Arm IIA
n=9 Participants
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
n=8 Participants
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
|---|---|---|---|---|
|
Number of Patients With Oral Mucositis by Grade
No of patients with grade 3, severe mucositis
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Oral Mucositis by Grade
No. of patients with grade 0, no mucositis
|
3 participants
|
4 participants
|
6 participants
|
3 participants
|
|
Number of Patients With Oral Mucositis by Grade
No. of patients with grade 1, mild mucositis
|
0 participants
|
4 participants
|
2 participants
|
3 participants
|
|
Number of Patients With Oral Mucositis by Grade
No of patients with grade 2, moderate mucositis
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Patients With Oral Mucositis by Grade
No. of patients with grade 4, disabling mucositis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Oral Mucositis by Grade
No. of patients with grade 5 mucositis, death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at baseline, at 1 month, 3 months and 6 months post-chemoradiationPopulation: Due to loss of funding, sufficient data for analysis was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at baseline, at 1 month, 3 months and 6 months post-chemoradiationPopulation: Due to loss of funding, sufficient data for analysis was not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Arm IA
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm IB
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm IIA
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm IIB
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm IA
n=8 participants at risk
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=12 participants at risk
Patients undergo SNT and low weight resistance training (LWRT).
|
Arm IIA
n=12 participants at risk
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
n=9 participants at risk
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
accute hearing loss
|
0.00%
0/8
|
0.00%
0/12
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
mucositis/stomatitis-oral cavity
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Muscle weakness - lower extremity
|
0.00%
0/8
|
0.00%
0/12
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Pain - abdomen NOS
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
General disorders
pain - larynx
|
0.00%
0/8
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
pain - oral cavity
|
0.00%
0/8
|
0.00%
0/12
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
General disorders
pain - NOS
|
0.00%
0/8
|
0.00%
0/12
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
pain - rectal
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Fever-in absence of neutropenia
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Rigor, chills
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Investigations
weight loss
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-blood
|
0.00%
0/8
|
0.00%
0/12
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
|
General disorders
edema limb
|
0.00%
0/8
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
Arm IA
n=8 participants at risk
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Arm IB
n=12 participants at risk
Patients undergo SNT and low weight resistance training (LWRT).
|
Arm IIA
n=12 participants at risk
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
n=9 participants at risk
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
87.5%
7/8 • Number of events 22
|
83.3%
10/12 • Number of events 23
|
75.0%
9/12 • Number of events 24
|
66.7%
6/9 • Number of events 14
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
4/8 • Number of events 8
|
25.0%
3/12 • Number of events 4
|
25.0%
3/12 • Number of events 4
|
33.3%
3/9 • Number of events 4
|
|
Gastrointestinal disorders
difficulty chewing
|
75.0%
6/8 • Number of events 17
|
91.7%
11/12 • Number of events 30
|
75.0%
9/12 • Number of events 29
|
88.9%
8/9 • Number of events 23
|
|
Gastrointestinal disorders
dysphagia
|
87.5%
7/8 • Number of events 32
|
100.0%
12/12 • Number of events 46
|
83.3%
10/12 • Number of events 42
|
88.9%
8/9 • Number of events 34
|
|
Gastrointestinal disorders
mucositis
|
87.5%
7/8 • Number of events 29
|
100.0%
12/12 • Number of events 40
|
75.0%
9/12 • Number of events 33
|
88.9%
8/9 • Number of events 32
|
|
Gastrointestinal disorders
nausea
|
87.5%
7/8 • Number of events 21
|
50.0%
6/12 • Number of events 13
|
66.7%
8/12 • Number of events 17
|
88.9%
8/9 • Number of events 15
|
|
Gastrointestinal disorders
vomiting
|
75.0%
6/8 • Number of events 13
|
50.0%
6/12 • Number of events 12
|
66.7%
8/12 • Number of events 12
|
66.7%
6/9 • Number of events 8
|
|
Gastrointestinal disorders
dry mouth
|
87.5%
7/8 • Number of events 32
|
100.0%
12/12 • Number of events 46
|
83.3%
10/12 • Number of events 40
|
88.9%
8/9 • Number of events 31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place