NCT00053053 is a Phase 3 clinical trial of Juven in Cachexia, sponsored by Radiation Therapy Oncology Group.

Who is sponsoring NCT00053053?

NCT00053053 is sponsored by Radiation Therapy Oncology Group.

What drugs are being tested in NCT00053053?

Interventions in NCT00053053: Juven, Non-Juven Supplement.

What condition does NCT00053053 study?

NCT00053053 studies Cachexia, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific.

Is NCT00053053 still recruiting?

NCT00053053 is currently completed. Last updated 6 December 2016.

Last reviewed 2016-12-06 · How we verify

NCT00053053

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

Completed Phase 3 Last updated 6 December 2016

What this trial tests

Phase 3 trial testing Juven in Cachexia in 472 participants. Completed in 1 February 2009.

Timeline

1 December 2002

Primary endpoint
1 March 2005

1 February 2009

Quick facts

Lead sponsor	Radiation Therapy Oncology Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	472
Start date	1 December 2002
Primary completion	1 March 2005
Estimated completion	1 February 2009
Sites	250 locations across United States, Canada

Drugs / interventions tested

Juven — full drug profile →
Non-Juven Supplement

Conditions studied

Cachexia — all drugs for Cachexia →
Lymphoma — all drugs for Lymphoma →
Lymphoproliferative Disorder — all drugs for Lymphoproliferative Disorder →
Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

Radiation Therapy Oncology Group — full company profile →

Who can join

Adults 17 to 120, any sex, with Cachexia or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Lean body mass
Time frame: Study entry to 8 weeks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Dietary fat and lipid metabolism in the tumor microenvironment.
Goswami S, Zhang Q, Celik CE, Reich EM, et al · · 2023 · cited 21× · PMID 37722512 · DOI 10.1016/j.bbcan.2023.188984

Verify or expand the search:

Other trials of Juven

Trials testing the same drug.

NCT05971173 — Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery · EARLY_PHASE1 · completed
NCT03658278 — Trauma Screening and Supplementation · NA · completed

Other recruiting trials for Cachexia

Currently open trials in the same condition.

NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
NCT07338487 — A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Canc · Phase 1 · recruiting
NCT07288619 — Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease · NA · active not recruiting
NCT06989437 — A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Signif · Phase 2, PHASE3 · recruiting
NCT07130981 — Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients · recruiting

Other Radiation Therapy Oncology Group trials

Trials by the same sponsor.

NCT01711658 — TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. · Phase 2 · completed
NCT01730950 — Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma · Phase 2 · completed
NCT01349322 — Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients · Phase 3 · active not recruiting
NCT03722355 — Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00053053 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radiation Therapy Oncology Group
Last refreshed: 6 December 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00053053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing