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Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer Clinical research trials and Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer. Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer  Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
For Condition: Head and Neck Cancer,Salivary Gland Cancer,lip and oral cavity cancer,Oropharyngeal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Iseganan hydrochloride may be effective in preventing or lessening oral mucositis in patients who are receiving radiation therapy for head and neck cancer. It is not yet known if iseganan hydrochloride is effective in preventing oral mucositis. PURPOSE: Randomized phase III trial to determine the effectiveness of iseganan hydrochloride in preventing oral mucositis in patients who are receiving radiation therapy for head and neck cancer.
Details: OBJECTIVES: I. Compare the efficacy and safety of iseganan HCl oral solution vs placebo in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. II. Compare the effects of these treatments on mouth pain, ability to swallow, weight loss, and the distribution of oral mucositis in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to radiotherapy (conventional fractionating radiotherapy vs hyperfractionating or concurrent boost radiotherapy) and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 3 arms. Arm I: Patients rinse with iseganan HCl oral solution 6 times daily. Treatment continues for duration of scheduled radiotherapy. Arm II: Patients rinse with oral placebo 6 times daily. Treatment continues for the duration of the scheduled radiotherapy. Arm III: Patients receive standard-of-care supportive treatment. Oral cavity pain, ability to swallow, and weight loss are assessed twice weekly and on follow-up days 28 and 56. Patients are followed on days 28 and 56. PROJECTED ACCRUAL: A total of 504 patients (252 for arm I, 168 for arm II, and 84 for arm III) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignancy of the head and neck, including cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, or salivary glands - Undergoing or planning to undergo radiotherapy to the head and neck involving: Bilateral treatment with either conventional, hyperfractionated, or concurrent boost external beam radiotherapy; Minimum total radiation dose of 60 Gy to at least 3 sites within the oral cavity; Total scheduled administration of no more than 8 weeks - No oral mucositis already present; Ulceration related to head and neck malignancy or prior surgery allowed --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Concurrent chemotherapy allowed - Endocrine therapy: No concurrent topical corticosteroids to oral cavity - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics - Other: At least 30 days since prior investigational agent for prevention and/or treatment of mucositis; No prior participation in this study; No concurrent topical anesthetics, such as lidocaine or dyclonine hydrochloride, within 30 minutes before or 15 minutes after study agent; No concurrent oral rinses within 15 minutes of study agent --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Must be able to orally rinse with study drug; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuyJuillard, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068810; UCLA-0008049,NCI-G01-2001,IBP-PG-015
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022373
Other Head And Neck Cancer Studies:
1. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
2. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
3. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
4. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
5. Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
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