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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04131426
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
Smartfish AS
Information provided by (Responsible Party):
Richard Dunne, University of Rochester

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 Nutritional Supplement Lung Cancer Gastrointestinal Cancer Dietary Supplement: 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : January 30, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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
Dietary Supplement: 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
Dietary Supplement: 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 Name: Exercise for Cancer Patients

No Intervention: Usual Care
Usual standard care as prescribed by your oncologist



Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 3 months ]
    measured by adverse event severity and quantity

  2. Number of patients that adhered to the dietary conditions of the study [ Time Frame: 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

  3. Number of patients that adhered to the exercise conditions of the study [ Time Frame: 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 :
  1. Proportion of subjects that improve physical function- Walking [ Time Frame: 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.

  2. Proportion of subjects that improve physical function- Power [ Time Frame: 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).

  3. Proportion of subjects that improve physical function- Muscle Strength [ Time Frame: 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.

  4. Proportion of subjects with decreased fatigue [ Time Frame: 3 months ]
    The Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-F), has been validated for use with older adults and is appropriate for those who may be functionally impaired as a result of cachexia. The FACIT-F is a short, 13-item tool directly related to the impact of fatigue on daily activities over the past week. The level of fatigue is measured on a four point Likert scale (0 = not at all fatigued to 4 = very much fatigued).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (patients unable to perform 6-minute walk or stair climb test will be allowed to participate, but will be held out of these measurements).
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131426


Contacts
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Contact: Robin Boerman 585-273-1507 Robin_Boerman@URMC.Rochester.edu

Sponsors and Collaborators
University of Rochester
Smartfish AS
Investigators
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Principal Investigator: Richard Dunne University of Rochester Wilmot Cancer Center

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Responsible Party: Richard Dunne, Associate Professor - Department of Medicine , Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT04131426    
Other Study ID Numbers: UMLT19130
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Richard Dunne, University of Rochester:
Cachexia; Cancer
Weight Loss
Exercise
Nutritional Supplement
Lung Cancer
Gastrointestinal Cancer
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Wasting Syndrome
Weight Loss
Cachexia
Neoplasms by Site
Neoplasms
Body Weight
Signs and Symptoms
Body Weight Changes
Emaciation
Metabolic Diseases
Nutrition Disorders
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases