Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053053
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2003-01-27
Brief Title:
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven Nutritional Supplement
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Compare the change in lean body mass of patients treated with Juven vs a non-Juven supplement
Compare the change in fatigue and quality of life of patients treated with these supplements
Compare the results of plethysmography bioimpedance and skinfold measurement in patients treated with these supplements
Compare the weight change in patients treated with these supplements
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
Arm I Patients receive oral Juven supplement twice daily for 8 weeks
Arm II Patients receive oral non-Juven supplement twice daily for 8 weeks All patients undergo lean body mass measurement to include multiple body composition and weight change and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks
PROJECTED ACCRUAL A total of 468 patients 234 per treatment arm will be accrued for this study within 16 months
Compare the change in lean body mass of patients treated with Juven vs a non-Juven supplement
Compare the change in fatigue and quality of life of patients treated with these supplements
Compare the results of plethysmography bioimpedance and skinfold measurement in patients treated with these supplements
Compare the weight change in patients treated with these supplements
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
Arm I Patients receive oral Juven supplement twice daily for 8 weeks
Arm II Patients receive oral non-Juven supplement twice daily for 8 weeks All patients undergo lean body mass measurement to include multiple body composition and weight change and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks
PROJECTED ACCRUAL A total of 468 patients 234 per treatment arm will be accrued for this study within 16 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000269100 | None | None | None |