|
RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician 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 website committed 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally 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 typically receive the most expert healthcare available 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 more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Salivary Gland Cancer Studies:
1. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent 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. Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
5. Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Related Studies:
Other Salivary Gland Cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
|
|
|
|
|
|
|
|
