NCT04131426

Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia

Completed Phase 1 Last updated 15 August 2023

What this trial tests

Phase 1 trial testing Remune in Cachexia; Cancer in 25 participants. Completed in 1 April 2022.

Timeline

24 April 2020

Primary endpoint
13 January 2021

1 April 2022

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	25
Start date	24 April 2020
Primary completion	13 January 2021
Estimated completion	1 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Remune — full drug profile →
• EXCAP©®

Conditions studied

• Cachexia; Cancer — all drugs for Cachexia; Cancer →
• Weight Loss — all drugs for Weight Loss →
• Lung Cancer — all drugs for Lung Cancer →
• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Cachexia; Cancer or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer cachexia: molecular mechanisms and treatment strategies.
   Setiawan T, Sari IN, Wijaya YT, Julianto NM, et al · · 2023 · cited 176× · PMID 37217930 · DOI 10.1186/s13045-023-01454-0
2. Muscle wasting in cancer: opportunities and challenges for exercise in clinical cancer trials.
   Fairman CM, Lønbro S, Cardaci TD, VanderVeen BN, et al · · 2022 · cited 28× · PMID 36118249 · DOI 10.1002/rco2.56
3. Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.
   Cencioni C, Trestini I, Piro G, Bria E, et al · · 2022 · cited 24× · PMID 35458104 · DOI 10.3390/nu14081542
4. Cancer cachexia: molecular basis and therapeutic advances.
   Tan Y, Xue R, Pan Y, He Z, et al · · 2026 · cited 3× · PMID 41526343 · DOI 10.1038/s41392-025-02331-7
5. Combined Nutritional and Exercise Interventions for Cachexia in Chronic Diseases: A Systematic Review and Meta-analysis Limited to Cancer Cachexia.
   Okamura M, Shirado K, Shirai N, Yagi T, et al · · 2026 · PMID 41884877 · DOI 10.2490/prm.20260012
6. Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
   Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284