|
Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis Clinical research trials and Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis. Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis clinical trial. Participants frequently get the best healthcare available for their Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis  Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
For Condition: Fibrosis,Radiation Injuries
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.
Details: Patients with late fibrovascular sequelae of radiation or of combined radiation and surgery, with quantifiable symptomatology or disability, will be eligible for this trial. This protocol is designed as an open label one arm study. (A placebo controlled randomized trial was approved by the IRB but after extensive negotiation, drug and placebo in slow release formulation will not be provided by the manufacturer). Up to fifty patients will be recruited. After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response. In addition to symptomatic objective and subjective response, blood and urine will be collected for TNF, TGF-beta, and FGF. Cutaneous blood flow and collagen subtyping will be performed on a subset of patients using Laser Doppler, functional MRI techniques and subcutaneous tissue biopsies. We will examine for correlation between clinical response and these biological responses.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950138; 95-C-0138
Study Start Date: June 1, 1995
Record last reviewed: May 28, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001437
Other Radiation Injuries Studies:
1. Pirfenidone to Treat Radiation-Induced Fibrosis
2. Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
3. Combination Drug Therapy for Patients with Hepatitis C
4. Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
Related Studies:
Other Radiation Injuries Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Trial of Pentoxifylline in Patients with Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
|
|
|
|
|
|
|
|
