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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053053 |
Purpose
RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Cachexia Lymphoma Lymphoproliferative Disorder Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: Juven |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| Official Title: | A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement |
| Study Start Date: | December 2002 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to primary disease site (lung vs others), concurrent chemotherapy (yes vs no), evidence of metastases (yes vs no), and degree of weight loss (2-5% vs 6-10%). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic aspect
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
No concurrent intestinal obstruction
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 250 Study Locations| Study Chair: | Lawrence B. Berk, MD, PhD | CCOP - Columbus |
More Information
| Study ID Numbers: | CDR0000269100, RTOG-0122 |
| Study First Received: | January 27, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053053 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific cachexia recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma |
stage III adult diffuse small cleaved cell lymphoma stage III adult Burkitt lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Burkitt lymphoma stage IV adult Hodgkin lymphoma |
|
Immunoproliferative Disorders Disease Neoplasms by Histologic Type Immune System Diseases Cachexia Emaciation Body Weight Lymphatic Diseases Signs and Symptoms |
Neoplasms Pathologic Processes Lymphoma, Large-Cell, Immunoblastic Weight Loss Body Weight Changes Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |