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

Sponsor

University of Rochester (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04131426

Collaborator

Smartfish AS (Industry)

Enrollment

Location

Arms

44.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cachexia; Cancer Weight Loss Lung Cancer Gastrointestinal Cancer	Drug: Remune Other: EXCAP©®	Phase 1

Detailed Description

In this study the investigator would like to better understand how cachexia may improve or worsen, and how exercise and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or exercise may affect different markers in the blood over time.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluating the Effects of Dietary Supplementation With Remune on Cancer Associated Weight and Muscle Loss With and Without Exercise: A Randomized Pilot Feasibility Study.

Actual Study Start Date :

Apr 24, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remune dosed twice daily A nutritional supplement taken twice per day each day and standard care for your cancer as prescribed by your oncologist	Drug: Remune Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD
Experimental: Remune dosed twice daily and daily exercise with EXCAP 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 Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD Other: EXCAP©® EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises Other Names: Exercise for Cancer Patients
No Intervention: Usual Care Usual standard care as prescribed by your oncologist

Arm

Intervention/Treatment

Experimental: Remune dosed twice daily

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

Drug: Remune

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

Experimental: Remune dosed twice daily and daily exercise with EXCAP

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

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

Other: EXCAP©®

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

Other Names:

Exercise for Cancer Patients

No Intervention: Usual Care

Usual standard care as prescribed by your oncologist

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [3 months]
measured by adverse event severity and quantity
Number of patients that adhered to the dietary conditions of the study [3 months]
Measure adherence to and compliance of patients with the dietary study conditions will be monitored via the use of the Daily Diary, which patients complete each evening. Patients are asked to report the number of cartons of Remune consumed each day and how much they consumed
Number of patients that adhered to the exercise conditions of the study [3 months]
Adherence to and compliance of patients with the exercise study conditions will be monitored via the use of the Daily Diary, which patients complete each evening. Subjects are asked to report the the frequency, intensity and total minutes spent doing each individual physical exercise each day

Secondary Outcome Measures

Proportion of subjects that improve physical function- Walking [3 months]
6 minute walk test distance; Participants are given a short warm up and cool down walking protocol in the test walking area in the University. During the 6-minute walk, participants will be asked to wear a sensor that will measure movement ability. The sensor is secured by an ergonomic belt around the participant's waist and allows for free body movement and comfort. Participants walk for a total of 6 minutes and cover as much distance as they can during this time. Upon completion of the test, the total distance walked is used to measure physical performance.
Proportion of subjects that improve physical function- Power [3 months]
Power will be assessed by the Stair Climb Performance Test (SCPT) which is performed by having subjects safely ascend a flight of stairs (approximately 10 stairs total) as quick and as safely as possible with supervision. The subject can use the handrail as a safety precaution if deemed necessary by the patient, physician, coordinator, or exercise physiologist. Power is calculated by force (calculated by body mass and acceleration due to gravity) multiplied by the velocity (distance/time).
Proportion of subjects that improve physical function- Muscle Strength [3 months]
Muscular strength will be assessed objectively using The Handgrip Dynamometer Test. The Handgrip Dynamometer Test is a grip strength test used to assess the maximal voluntary contraction generated by the arm muscles. The test is administered with the patient standing with the elbow joint angle held constant at 180 degrees and the medial distal humeral epicondyle held 2 inches from the torso. Trials will be performed in an alternating bilateral sequence, for a total of six attempts (three with each arm). The best score of the three hand-grip trials will be used for right and left limbs to calculate static strength.
Porportion of subjects with improved cachexia-related symptoms 3 months [3 months]
The Functional Assessment of Anoreix/Cachexia Therapy subscale is a 39-item questionnaire that measures general aspects of quality of life as well as specific anorexia/cachexia-related concerns. This will be collected at pre- and post intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.