ClinicalTrials.gov
ClinicalTrials.gov Menu

Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

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: NCT00040365
Recruitment Status : Completed
First Posted : June 26, 2002
Results First Posted : March 29, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Prostatic Neoplasms
Interventions Drug: Amifostine trihydrate
Radiation: Radiation therapy
Enrollment 30
Recruitment Details This trial accrued 30 participants.
Pre-assignment Details  
Arm/Group Title Amifostine
Hide Arm/Group Description 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Period Title: Overall Study
Started 30
Completed Follow Up Phase 19
Completed 19
Not Completed 11
Reason Not Completed
Death             1
Progressive disease             7
Lost to Follow-up             3
Arm/Group Title Amifostine
Hide Arm/Group Description 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  60.0%
>=65 years
12
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
65.63  (7.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
3
  10.0%
Not Hispanic or Latino
27
  90.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Asian 2
Black 2
White 23
Hispanic 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.
Hide Description A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx
Time Frame RTOG Acute was used on week 5 and 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Percentage of Participants
20.69
2.Secondary Outcome
Title Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.
Hide Description A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.
Time Frame The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Percentage of Participants
83.33
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
30
4.Secondary Outcome
Title Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)
Hide Description The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.6  (0.1)
5.Secondary Outcome
Title Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)
Hide Description Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.
Time Frame Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: scores on a scale
Baseline bowel function
91.13
(71.43 to 100)
Baseline bowel bother
92.86
(67.86 to 100)
Week 5 bowel function
71.43
(39.29 to 96.43)
Week 5 bowel bother
67.33
(28.57 to 100)
Week 5 RTOG
1.06
(0 to 2)
Week 7 bowel function
69.76
(32.14 to 100)
Week 7 bowel bother
66.38
(21.43 to 96.43)
Week 7 RTOG
1.00
(0 to 2)
1 month bowel function
84.09
(42.86 to 100)
1 month bowel bother
78.08
(32.14 to 96.43)
1 month RTOG
0.59
(0 to 1)
3 month bowel function
79.08
(46.43 to 100)
3 month bowel bother
82.78
(17.86 to 100)
3 month RTOG
0.54
(0 to 2)
6 month bowel function
85.46
(50 to 100)
6 month bowel bother
81.86
(50 to 100)
6 month RTOG
0.39
(0 to 1)
12 month bowel function
83.92
(39.29 to 100)
12 month bowel bother
77.65
(10.71 to 100)
12 month RTOG
0.50
(0 to 2)
18 month bowel function
83.55
(50 to 100)
18 month bowel bother
76.28
(14.29 to 100)
18 month RTOG
0.64
(0 to 2)
6.Secondary Outcome
Title Number of Participants Who Had Proctoscopic Examinations
Hide Description Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amifostine
Hide Arm/Group Description:
1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
30
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amifostine
Hide Arm/Group Description 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
All-Cause Mortality
Amifostine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amifostine
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Gastrointestinal disorders   
Proctitis   1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amifostine
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
hematochezia  [1]  6/30 (20.00%)  7
Cardiac disorders   
cardiac-ischemia/infarction  [1]  1/30 (3.33%)  1
palpitations  [1]  1/30 (3.33%)  1
Endocrine disorders   
Hot Flashes  [1]  1/30 (3.33%)  1
hot flashes/flushes  [1]  5/30 (16.67%)  10
Gastrointestinal disorders   
Constipation  [1]  1/30 (3.33%)  1
diarrhea  [1]  25/30 (83.33%)  42
Dry mouth  [1]  1/30 (3.33%)  1
flatulence  [1]  9/30 (30.00%)  9
mucositis  [1]  20/30 (66.67%)  29
mucous membrane  [1]  19/30 (63.33%)  28
nausea  [1]  3/30 (10.00%)  4
other-edema (mucosal edema; redness)  [1]  1/30 (3.33%)  1
other-mucositis (erythema)  [1]  2/30 (6.67%)  3
other-rectal spasm  [1]  1/30 (3.33%)  1
other-tenesmus  [1]  2/30 (6.67%)  2
proctitis  [1]  29/30 (96.67%)  89
sm/ lg bowel  [1]  28/30 (93.33%)  89
taste disturbance  [1]  1/30 (3.33%)  1
vomiting  [1]  1/30 (3.33%)  1
Small/large bowel  [2]  28/30 (93.33%)  89
General disorders   
chills  [1]  1/30 (3.33%)  1
fatigue  [1]  27/30 (90.00%)  48
weight gain  [1]  13/30 (43.33%)  20
weight loss  [1]  11/30 (36.67%)  11
Immune system disorders   
allergic reaction/hypersensitivity  [1]  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
arthralgia  [1]  5/30 (16.67%)  6
Hip Pain  [1]  1/30 (3.33%)  1
Knee  [1]  1/30 (3.33%)  1
neck/shoulder  [1]  1/30 (3.33%)  1
other- back (d/t bulge disc (L1-L2P)  [1]  2/30 (6.67%)  2
other-knee injury (orthopedic evaluation)  [1]  1/30 (3.33%)  1
other-L arm  [1]  1/30 (3.33%)  1
other-low back (d/t osteophytes (MRI); Celebrex; Advil)  [1]  1/30 (3.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
other-tubular adenoma (colonoscopy/bx 12/19/05)  [1]  1/30 (3.33%)  1
Nervous system disorders   
chest pain  [1]  1/30 (3.33%)  1
CN. VI  [1]  1/30 (3.33%)  1
headache  [1]  1/30 (3.33%)  1
mood alteration- depression  [1]  22/30 (73.33%)  34
neuropathy-sensory  [1]  3/30 (10.00%)  4
other-L side  [1]  1/30 (3.33%)  1
Pain: Headaches  [1]  1/30 (3.33%)  1
syncope  [1]  1/30 (3.33%)  1
Tremor-arms  [1]  1/30 (3.33%)  1
Psychiatric disorders   
insomnia  [1]  2/30 (6.67%)  2
Renal and urinary disorders   
bladder  [1]  1/30 (3.33%)  1
dysuria  [1]  16/30 (53.33%)  24
Genitourinary  [1]  1/30 (3.33%)  1
hematuria  [1]  4/30 (13.33%)  5
incontinence  [1]  23/30 (76.67%)  34
other-weak stream (ibuprofen)  [1]  20/30 (66.67%)  32
other-burning (burning with urination; burning in penis; Cipro)  [1]  1/30 (3.33%)  3
other-pressure (incr pressure urinary stream)  [1]  1/30 (3.33%)  1
urinary frequency/urgency  [1]  27/30 (90.00%)  57
urinary retention  [1]  21/30 (70.00%)  36
Bladder  [3]  1/30 (3.33%)  1
Reproductive system and breast disorders   
abdominal pain/cramping  [4]  4/30 (13.33%)  5
erectile dysfunction  [1]  3/30 (10.00%)  3
erectile impotence  [1]  18/30 (60.00%)  24
libido  [1]  6/30 (20.00%)  6
orgasmic dysfunction  [1]  1/30 (3.33%)  1
other-breast tenderness  [1]  3/30 (10.00%)  3
other-ejaculate (Cipro)  [1]  3/30 (10.00%)  3
Respiratory, thoracic and mediastinal disorders   
cough  [1]  2/30 (6.67%)  2
dyspnea  [1]  4/30 (13.33%)  4
Skin and subcutaneous tissue disorders   
alopecia  [1]  1/30 (3.33%)  1
dry skin  [1]  1/30 (3.33%)  1
erythema  [1]  3/30 (10.00%)  3
injection site reaction  [1]  1/30 (3.33%)  1
other-body hair loss  [1]  1/30 (3.33%)  1
other-local swelling (r/t IL-2 injection)  [1]  1/30 (3.33%)  1
pruritis  [1]  8/30 (26.67%)  9
radiation dermatitis  [1]  1/30 (3.33%)  1
Mucous membrane  [2]  19/30 (63.33%)  28
Vascular disorders   
hypotension  [1]  1/30 (3.33%)  1
thrombosis/embolism  [1]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
CTCv2.0 AE
[2]
RTOG AE
[3]
Radiation Therapy Oncology Group (RTOG) Adverse Event (AE)
[4]
Common Toxicity Criteria (CTC) v2.0 Adverse Event (AE)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kevin A. Camphausen
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-5457
Publications of Results:
Simone, NL; Soule, BP; Ménard, C; Albert, P; Guion, P; Smith, S; Godette, D; Coleman, CN; Singh, AK. Assessing Rectal Toxicity in a Pilot Study using Intrarectal Amifostine and Concurrent Radiation. 42nd annual meeting of the American society of clinical oncology, Atlanta, GA, June 2006.
Menard, C; Camphausen, K; Muanza, T; Crouse, N; Smith, S; Ben-Josef, E; Coleman, C.N. (2003). Intrarectal Ethyol for Radioprotection in Prostate Cancer. Rationale and Early Results. Abstract: 3rd International Cytoprotection Investigator's Congress
Responsible Party: Kevin A. Camphausen, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00040365     History of Changes
Obsolete Identifiers: NCT00045253
Other Study ID Numbers: 020215
02-C-0215
First Submitted: June 25, 2002
First Posted: June 26, 2002
Results First Submitted: January 13, 2012
Results First Posted: March 29, 2012
Last Update Posted: April 30, 2012