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

NCT04131426 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: UMLT19130
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cachexia; Cancer; Weight Loss; Lung Cancer; Gastrointestinal Cancer

Keywords

Cachexia; Cancer; Weight Loss; Exercise; Nutritional Supplement; Lung Cancer; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  measured by adverse event severity and quantity

  3 months

• Adherance

  Did 70% of subjects in the supplement arm consume 60% of supplement evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed

  3 months

• Recruitment and Retention

  Recruitment of 45 patients (15 per arm) and at least 10 evaluable patients in each arm for retention rate of 66%

  3 months

Secondary Outcomes (4)

• Proportion of subjects that improve physical function- Walking

  3 months

• Proportion of subjects that improve physical function- Power

  3 months

• Proportion of subjects that improve physical function- Muscle Strength

  3 months

• Porportion of subjects with improved cachexia-related symptoms 3 months

  3 months

Study Arms (3)

Remune dosed twice daily

EXPERIMENTAL

A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist

Drug: Remune

Remune dosed twice daily and daily exercise with EXCAP

EXPERIMENTAL

A nutritional supplement taken twice by day each day and a home-based exercise intervention as well as standard care for your cancer as prescribed by your oncologist

Drug: Remune; Other: EXCAP©®

Usual Care

NO INTERVENTION

Usual standard care as prescribed by your oncologist

Interventions

Remune DRUG

Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD

Remune dosed twice daily; Remune dosed twice daily and daily exercise with EXCAP

EXCAP©® OTHER

EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises

Also known as: Exercise for Cancer Patients

Remune dosed twice daily and daily exercise with EXCAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over the age of 18 years and have a primary diagnosis of colorectal, esophageal, gastric, pancreatic, biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer), or Non-small cell lung cancer (NSCLC) with plans to initiate systemic chemotherapy, targeted therapy or immunotherapy within the next 4 weeks after enrollment.
• Have been diagnosed as having an unresectable cancer with no plans for surgical intervention during the active study period (12 weeks).
• Have an ECOG performance score of 0 or 1.
• Have a life expectancy of \>3 months as determined by their primary oncologist.
• Have experienced at least 2% weight loss of the patient's reported previous body weight over the 6 months prior to enrollment.
• Have permission from primary oncologist to engage in low to moderate intensity exercise regimen.
• Be able to read English (since the assessment materials are in printed format).
• Be able to give written informed consent.

You may not qualify if:

• Have any of the following limitations: unable to perform low-to-moderate intensity exercise regimen.
• Have had major surgery (excluding diagnostic procedures like laparoscopy, EGD/EUS, esophageal stent placement) in the past 4 weeks.
• Be experiencing dysphagia that requires enteral or parenteral feeding for nutrition.
• Be enrolled on hospice at time of consent.
• Be engaged in an active exercise routine by being identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (67).
• Use of nutritional supplements containing EPA/DHA within 2 weeks prior to screening
• Current Use of Vitamin D supplementation or St. John's wort that can influence efficacy and safety parameters. Chronic treatment (\>12 weeks prior to screening) with multivitamin tablets is allowed (vitamin tablets must not contain more vitamin D than 150% of the recommended dietary allowance \[RDA\]).
• Known hypersensitivity or allergy to any of the study products. Specifically, patients allergic to milk, fish or shellfish will be excluded.
• Have AST/ALT \>3x upper limit of normal (ULN) or \>5xULN in those with liver metastases, Serum creatinine \>2x ULN, Absolute Neutrophil Count \<1,500/uL, Hemoglobin \<9, Platelet count \<75,000/uL at the time of baseline blood draw or any other Blood chemistry or hematology lab abnormalities that would exclude them from being able to receive standard chemotherapy or interventional clinical trial.
• Have uncontrolled Diabetes Mellitus as determined by primary oncologist or PI.

Sponsors & Collaborators

• University of Rochester: lead
• Smartfish AS: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cachexia; Neoplasms; Weight Loss; Lung Neoplasms; Gastrointestinal Neoplasms; Motor Activity

Interventions

remune; Exercise

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Richard Dunne

  University of Rochester Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Medicine , Hematology/Oncology

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 18, 2019
• Study Start: April 24, 2020
• Primary Completion: January 13, 2021
• Study Completion: April 1, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

US (1)