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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001437 |
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Date of registration:
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03/11/1999 |
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Primary sponsor: |
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Public title:
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Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
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Scientific title:
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Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis |
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Date of first enrolment:
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June 1995 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001437 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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POPULATION CHARACTERISTICS:
Regional advanced postradiation fibrosis of the neck, chest wall, pelvis, or extremities
causing measurable impairment of specific function, i.e.: Decreased range of motion,
Weakness, Sensory deficit, Pain requiring narcotics, Significantly altered activities of
daily living.
None of these conditions present either before or during radiotherapy or attributed to
surgery or chemotherapy.
Patients with prostate cancer allowed if prostate-specific antigen (PSA) is less than 4.0
ng/mL and the last 3 PSA values were stable or decreasing. Abnormal bone scan or film
acceptable if consistent with degenerative disease.
No recurrent or metastatic cancer.
No concurrent second cancer.
PRIOR/CONCURRENT THERAPY: At least 3 months since pentoxifylline.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Karnofsky 70%-100% (unrelated to postradiation fibrosis).
CARDIOVASCULAR:
No symptomatic coronary artery disease with frequent anginal episodes necessitating any of
the following during past 6 months: Coronary artery bypass, Angioplasty, Pacemaker
placement, Thrombolytic treatment.
No chronic cardiac failure with persistent hemodynamic abnormality and ejection fraction
less than 40%.
No coagulation, platelet, or vascular disorder that threatens to cause bleeding.
OTHER:
No intolerance to pentoxifylline or other xanthines (e.g., caffeine, theophylline,
theobromine).
No seizure disorder.
No peptic ulcer disease.
Willing to undergo serial evaluations (excluding biopsies, laser Doppler, MRI) by NCI
rehabilitation specialist for documentation and grading of functional disability.
No pregnant or nursing women.
Adequate contraception encouraged in fertile women.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibrosis
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Radiation Injuries
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Intervention(s)
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Drug: pentoxifylline
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Secondary ID(s)
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95-C-0138
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950138
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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