H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols

Pain and Symptom Control


Pain Control Protocols

E-4Z93 Oral Analgesia Regimen for Improved Pain Control in Cancer Patients (Summary last modified 01/95).

Chairman: Charles Cleeland, University of Wisconsin, Madison, Wis. Lead organization: Eastern Cooperative Oncology Group, Brookline, Mass. Acceptable age range: 18 and over.

E-3Z93 Randomized Pilot Study to Evaluate Educational Intervention and Behavioral Skills Training for Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer (Summary last modified 01/96).

Chairman: Robert L. Coomis, Thomas Jefferson University Hospital, Philadelphia, Pa. Lead organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 and over.

YALE-HIC-8356 NCI-V96-0818 Study of Oral Transmucosal Fentanyl Citrate (OTFC) for the Treatment of Breakthrough Pain in Cancer Patients Currently Taking Transdermal Fentanyl (Summary last modified 05/96).

Chairman: Lloyd Saberski, Yale Comprehensive Cancer Center. Lead organization: Yale Comprehensive Cancer Center. Acceptable age range: 18 to 79.

YALE-HIC-8357 NCI-V96-0819 Study of Oral Transmucosal Fentanyl Citrate (OTFC) for the Treatment of Breakthrough Pain in Cancer Patients Currently Taking Other Opioids (Summary last modified 04/96).

Chairman: Lloyd Saberski, Yale Comprehensive Cancer Center. Lead organization: Yale Comprehension Cancer Center. Acceptable age range: age not specified.

Quality-of-Life Protocols

EORTC-06904 Assessment of Long-Term Quality of Life in Adult Acute Leukemia Patients Following Bone Marrow Transplantation or Intensive Chemotherapy (Summary last modified 12/92).

Chairman: K. Bjordal, Norwegian Radium Hospital, Oslo, Norway. Lead organization: EORTC Quality of Life Study Group. Acceptable age range: any age.

SWOG-9208 Companion Protocol to Evaluate Quality of Life and Health Status in Patients With Stage I/IIA Hodgkin's Disease Simultaneously Enrolled on SWOG-9133 or CLB-9391 (Summary last modified 05/95).

Chairman: Patricia Ganz, University of California-Los Angeles. Lead organization: Southwest Oncology Group, San Antonio, Tex. Acceptable age range: 18 and over.

MSKCC-94110 Evaluation of Quality of Life and Health Care Expenditures in Patients Receiving TAX for Stage IV Breast Cancer (Summary last modified 04/95).

Chairman: Andrew D. Seidman, Memorial Sloan-Kettering Cancer Center, New York, NY. Lead organization: Memorial Sloan-Kettering Cancer Center, New York, NY. Acceptable age range: 18 and over.

SWOG-8994 Evaluation of Quality of Life in Patients With Stage C Adenocarcinoma of the Prostate Enrolled on SWOG-8794 (INT-0086) (Summary last modified 10/90).

Chairman: Kathy Hayden, University of Arkansas, Little Rock, Ark. Lead organization: Southwest Oncology Group. Acceptable age range: any age.

EORTC-15941 International Field Study of the Reliability and Validity of the EORTC QLQ-C30 (Version 3.0) and a Diagnosis-Specific Module (the EORTC QLQ-H&N35) for the Assessment of Quality of Life in Patients With Head and Neck Cancer (Summary last modified 08/95).

Chairman: K. Bjordal, Norwegian Radium Hospital, Oslo, Norway. Lead organization: EORTC Quality of Life Study Group. Acceptable age range: any age.

EORTC-15931 International Field Study of the Reliability and Validity of the EORTC QLQ-C30 (Version 3.0) and the Disease-Specific Module (the EORTC QLQ-H&N35) for the Assessment of Quality of Life in Patients With Head and Neck Cancer (Summary last modified 10/95).

Chairman: K. Bjordal, Norwegian Radium Hospital, Oslo, Norway. Lead organization: EORTC Quality of Life Study Group. Acceptable age range: any age.

Stomatitis Protocols

NCCTG-959251 Phase III Randomized, Double-Blind, Placebo-Controlled Study of Glutamine to Alleviate Stomatitis in Patients Receiving Fluorouracil-Based Chemotherapy (Summary last modified 10/95).

Chairman: Michael J. O'Connell, Mayo Clinic, Rochester, Minn. Lead organization: North Central Cancer Treatment Group, Rochester, Minn. Acceptable age range: no age specified.

E-1Z93 Phase III Randomized Study of Sucralfate Suspension vs Topical Vitamin E for the Treatment of Chemotherapy-Induced Mucositis (Summary last modified 12/94).

Chairman: Lisa Stucky, Northwestern University, Chicago, Ill. Lead organization: Eastern Cooperative Oncology Group. Acceptable age range: 18 and over.

NCI-94-C-0123B Phase I Study of Transforming Growth Factor-beta-2 Administered as a Mouthwash to Alleviate Stomatitis in Patients Receiving Fluorouracil-Based Chemotherapy for Metastatic Cancer (Summary last modified 12/94).

Chairman: J. Mel Sorensen, Investigative Drug Branch, NCI, Bethesda, Md. Lead organization: Clinical Oncology Program, NCI, Bethesda, Md. Acceptable age range: 18 and over.

Miscellaneous Protocols

SWOG-9327 NCI-P94-0058 Phase II Randomized Pilot Study of Pentoxifylline vs Placebo for Anorexia and Cachexia in Patients With Metastatic Malignancies (Summary last modified 10/94).

Chairman: Raj Cheruku, Angelo Clinic Association. Lead organization: Southwest Oncology Group. Acceptable age range: adult.

GOG-9102 The Effect of Alopecia on the Cancer Patient's Body Image and the Role of Audiovisual Information on Improving Body Image (Summary last modified 05/95).

Chairman: Susan Nolte, Abington Memorial Hospital, Abington, Pa. Lead organization: Gynecologic Oncology Group. Acceptable age range: no age specified.

NCCTG-939252 Phase III Randomized, Double-Blind, Placebo-Controlled Study of Nortriptyline to Alleviate Symptoms of CDDP-Induced Peripheral Neuropathy (Summary last modified 10/94).

Chairman: Julie E. Hammack, Mayo Clinic, Rochester, Minn. Lead organization: North Central Cancer Treatment Group. Acceptable age range: over 18.

NCCTG-919252 Phase III Randomized Study of Megestrol Acetate vs Fluoxymesterone vs Dexamethasone for the Treatment of Cancer-Related and Cancer Treatment-Related Anorexia and Cachexia (Summary last modified 05/96).

Chairman: John W. Kugler, Oncology/Hematology Associates of Central Illinois, Peoria, Ill. Lead organization: North Central Cancer Treatment Group. Acceptable age range: 18 and over.

RTOG-9407 Randomized Study of Pentoxifylline and Best Supportive Care vs Best Supportive Care Only for Radiation-Induced Soft Tissue Necrosis in Cancer Patients (Summary last modified 07/95).

Chairman: Andy M. Trotti, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Fla. Lead organization: Radiation Therapy Oncology Group, Philadelphia, Pa. Acceptable age range: 18 and over.

SLLH-IRB93-0004 Study of the Efficacy and Safety of Complete Decongestive Physiotherapy in Patients With Post-Surgical Lower Extremity Lymphedema (Summary last modified 09/93).

Chairman: Arnold I. Walder, St. Luke's Lutheran Hospital, San Antonio, Tex. Lead organization: St. Luke's Lutheran Hospital, San Antonio, Tex. Acceptable age range: 18 and over.

NCI-95-C-0138A Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis (Summary last modified 04/96).

Chairman: Paul G. Okunieff, Radiation Oncology Branch, National Cancer Institute, Bethesda, Md. Lead organization: NCI. Acceptable age range: 18 and over.

Legend for Abbreviations:

E = Eastern Cooperative Oncology Group
EORTC = European Organization for Research on Treatment of Cancer
GOG = Gynecologic Oncology Group
MSKCC = Memorial Sloan-Kettering Cancer Center
NCCTG = North Central Cancer Treatment Group
NCI = National Cancer Institute
RTOG = Radiation Therapy Oncology Group
SLLH = St. Luke's Lutheran Hospital
SWOG = Southwest Oncology Group
YALE = Yale University


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