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Pirfenidone to Treat Radiation-Induced Fibrosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Pirfenidone to Treat Radiation-Induced Fibrosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Pirfenidone to Treat Radiation-Induced Fibrosis Clinical research trials and Pirfenidone to Treat Radiation-Induced Fibrosis healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Pirfenidone to Treat Radiation-Induced Fibrosis. Pirfenidone to Treat Radiation-Induced Fibrosis Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Pirfenidone to Treat Radiation-Induced Fibrosis clinical trial. Human subjects often receive the most effective healthcare possible for their Pirfenidone to Treat Radiation-Induced Fibrosis condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pirfenidone to Treat Radiation-Induced Fibrosis  Pirfenidone to Treat Radiation-Induced Fibrosis
Pirfenidone to Treat Radiation-Induced Fibrosis
For Condition: Fibrosis
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of the experimental anti-fibrotic drug pirfenidone in treating fibrosis (scar tissue) resulting from cancer radiation treatment. Fibrosis in the radiation-treated area is probably the most significant long-term side effect of this therapy. Depending on the area involved, fibrosis can lead to ulceration with poor wound healing, impaired range of motion, swallowing problems and neuropathy. Pirfenidone may prevent or remove excessive scar tissue found in fibrosis associated with injured tissues or organs such as the lung, skin, joints, kidney, prostate and liver. Patients 18 years of age and older with radiation-induced fibrosis causing at least moderate disability in range of motion, strength, pain, swelling, or swallowing may be eligible for this 2-year study. Candidates must have received radiation therapy more than 6 months before entering the study, and must have no evidence of active cancer or history of collagen vascular disease. Participants will be evaluated in the Clinical Center's Rehabilitation Medicine Department, where one symptom due to fibrosis will be selected for monitoring. They will then start treatment with pirfenidone pills, taken by mouth three times a day. Patients will return to the Clinical Center every 3 months for a physical examination and blood tests, and to complete questionnaires assessing level of daily functioning, pain, and other health and quality of life measurements. Some patients with scar tissue involving the skin will be asked to undergo spectroscopy. This test involves shining a light on parts of the skin both with and without fibrosis and taking measures of how the light is reflected back. Patients who benefit from the treatment may continue to receive pirfenidone for up to 2 years. Those who do not improve after 1 year of treatment, or whose cancer recurs will stop pirfenidone and be taken off the study.
Details: This study will assess the safety and effectiveness of pirfenidone as a treatment for fibrosis. Patients with radiation-induced fibrosis with quantifiable symptomatology or functional deficit will be eligible for this trial. After initial assessment of their functional status, patients will be administered daily oral pirfenidone. Objective and subjective response parameters will be assessed at regular intervals during the course of the study. Patients may remain on treatment for up to two years.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have regional post-radiation fibrosis of a specific body area (neck, back or extremities) causing at least moderate impairment in at least one of the following principal functional abilities: Range of Motion (ROM), strength, pain, edema, or swallowing as defined by standard rehabilitation measures. Patients must be willing to have serial evaluations by rehabilitation specialist at NIH for documentation and grading of functional disability. Patients must have received radiation more than 6 months ago. Patients must be willing and able to give informed consent. EXCLUSION CRITERIA: ECOG Performance status greater than 2. Evidence of recurrent or metastatic cancer or second primary cancer. Positive ANA or history of collagen vascular disease Age under 18. Pregnant or lactating women. Patients requiring rehabilitation intervention for life-threatening situation. Hepatitis B or C or HIV positivity.
Total Enrollment: 25
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010143; 01-C-0143
Study Start Date: April 4, 2001
Record last reviewed: February 2, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014924
Other Fibrosis Studies:
1. Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
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 Radiation-Induced Fibrosis
Related Studies:
Other Fibrosis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Pirfenidone to Treat Radiation-Induced Fibrosis
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