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RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands 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 RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands Clinical research trials and RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands 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 RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands 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 RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands 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 > "R" Clinical Trials Conditions > RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands  RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
For Condition: oral complications of cancer and cancer therapy,Salivary Gland Cancer,Oropharyngeal Cancer,Nasopharyngeal Cancer,radiation toxicity,lip and oral cavity cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: RK-0202 may be able to prevent oralmucositis in patients who are undergoing radiation therapy for cancer of the mouth, throat, or salivary glands. PURPOSE: Randomizedphase II trial to study the effectiveness of RK-0202 in preventing inflammation of the mouth in patients who are undergoing radiation therapy for cancer of the mouth, throat, or salivary glands.
Details: OBJECTIVES: - Compare the efficacy of 2 different doses of RK-0202 rinse on incidence, severity, and time to onset of oral mucositis in patients with tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region who are undergoing radiotherapy. - Determine the safety and tolerability of this drug in these patients. - Compare the effect of placebo mouthwash vs standard care in these patients. OUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are randomized to 1 of 4 arms. - Arm I: Patients receive oral RK-0202 mouthwash for 1 minute (gargle for 5 seconds) and then expectorate. RK-0202 is administered 6 times daily, with at least 1 dose administered 30 minutes before each radiotherapy treatment. - Arm II: Patients receive a different dose of RK-0202 administered as in arm I. - Arm III: Patients receive placebo mouthwash, which is administered on the same schedule as in arm I. - Arm IV: Patients receive standard care. Treatment in all arms begins on the first day of radiotherapy and continues until radiotherapy is completed. Patients are followed at 30 days and then at 3 and 12 months. PROJECTED ACCRUAL: A total of 105 patients (30 in each active drug arm, 30 in the placebo arm, and 15 in the standard care arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed tumors of the oral cavity, oropharynx, nasopharynx, salivary glands, or supraglottic region - Planned radiotherapy that would deliver a minimum of 60 Gy over 5-8 weeks to at least 2 cm - of 3 or more of the following oral cavity anatomical sites: - Upper or lower lip - Right or left buccal - Right or left lateral/ventral tongue - Right or left dorsal tongue - Right or left floor of mouth - Right or left soft palate - Right or left tonsil region - Right or left hard palate - Nasopharynx - Radiotherapy must begin within 9 weeks after prior surgery and regimens may comprise the following: - Single-dose daily fractionated regimen (daily maximum of 2.2 Gy) - Hyperfractionated regimen (daily maximum of 2.4 Gy) - Concurrent boost (daily maximum of 3.3 Gy during boost) - No oral mucositis present - No T1 or T2 glottic tumors PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious recent nonmalignant medical condition that would preclude study participation - No medical, sociological, or psychological impediment that would preclude study participation - No eating for 30 minutes before and after study drug administration - Able to undergo oral assessments PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the head and neck - No concurrent brachytherapy or interstitial implantation Surgery - See Disease Characteristics Other - At least 14 days since prior investigational drugs - No topical or oral medications for 30 minutes before and after study drug administration - No concurrent amifostine - No other concurrent investigational drugs - No other concurrent investigational or mucoprotective therapy for the prevention of oral mucositis including, but not limited to the following: - Beta-carotene - Tocopherol - Laser irradiation - Brushing the oral mucosa with silver nitrate prophylactically - Systemic transforming growth factor-beta - Misoprostol - Pentoxifylline - Leucovorin calcium - Allopurinol mouthwashes - Systemic keratinocyte growth factor - Pilocarpine - No concurrent oral rinses with hydrogen peroxide, sucralfate, or chlorhexidine gluconate
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuyJuillard, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Guy Juillard 310-825-7145
Additional Information:
Study ID Numbers: CDR0000257185; NCI-G02-2111,UCLA-0205011,RK-0202:02
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046956
Other Lip And Oral Cavity Cancer Studies:
1. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
2. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
3. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
4. Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
5. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
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