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Study of Branched-chain Amino Acids in Cancer Cachexia

Primary Purpose

Cancer Cachexia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pure Encapsulations Branched Chain Amino Acid powder
control group (no BCAAs provided)
Sponsored by
Western Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring oncology, cancer cachexia, cachexia anorexia,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older
  2. Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months
  3. Participants must have evaluable disease by RECIST 1.1 criteria17
  4. At least four (4) weeks from prior major surgery

  5. Participants must be cachectic as defined by the guidelines below18

    • >5% weight loss over the past 6 months (in absence of simple starvation); OR
    • BMI <20 and any degree of weight loss >2%; OR
    • Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%

  6. Participants must be anorexic as defined by reporting one of the following symptoms below3

    • Early satiety
    • Nausea/vomiting
    • Taste alterations
    • Smell alterations
    • Meat aversion

Exclusion Criteria:

  1. Patients taking Levadopa
  2. Patients with amyotrophic lateral sclerosis (ALS)
  3. Patients utilizing a percutaneous gastrostomy tube for drainage
  4. Patients unable to consume food or beverage orally
  5. Patients on any form of parenteral nutrition which contains BCAA.
  6. Serious non-healing wound, ulcer, or burn
  7. Patients who are pregnant or lactating
  8. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
  9. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment

    Control

    Arm Description

    (arm 1) consume five scoops total per day of Pure Encapsulations Branched Chain Amino Acid powder on an outpatient basis (take 2 scoops both in the morning and afternoon and 1 scoop in the evening)

    (arm 2): control group (no BCAAs provided)

    Outcomes

    Primary Outcome Measures

    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and LBM based on body weight in kg
    Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg)
    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).

    Secondary Outcome Measures

    Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).

    Full Information

    First Posted
    August 14, 2017
    Last Updated
    August 22, 2017
    Sponsor
    Western Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03253029
    Brief Title
    Study of Branched-chain Amino Acids in Cancer Cachexia
    Official Title
    Use of Branched-chain Amino Acids in Cancer Cachexia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawal of institutional support
    Study Start Date
    April 2015 (Anticipated)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Regional Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment (BIA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Cachexia
    Keywords
    oncology, cancer cachexia, cachexia anorexia,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    (arm 1) consume five scoops total per day of Pure Encapsulations Branched Chain Amino Acid powder on an outpatient basis (take 2 scoops both in the morning and afternoon and 1 scoop in the evening)
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    (arm 2): control group (no BCAAs provided)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pure Encapsulations Branched Chain Amino Acid powder
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    control group (no BCAAs provided)
    Primary Outcome Measure Information:
    Title
    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and LBM based on body weight in kg
    Description
    Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg)
    Time Frame
    12 weeks
    Title
    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
    Description
    Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months Participants must have evaluable disease by RECIST 1.1 criteria17 At least four (4) weeks from prior major surgery Participants must be cachectic as defined by the guidelines below18 >5% weight loss over the past 6 months (in absence of simple starvation); OR BMI <20 and any degree of weight loss >2%; OR Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2% Participants must be anorexic as defined by reporting one of the following symptoms below3 Early satiety Nausea/vomiting Taste alterations Smell alterations Meat aversion Exclusion Criteria: Patients taking Levadopa Patients with amyotrophic lateral sclerosis (ALS) Patients utilizing a percutaneous gastrostomy tube for drainage Patients unable to consume food or beverage orally Patients on any form of parenteral nutrition which contains BCAA. Serious non-healing wound, ulcer, or burn Patients who are pregnant or lactating Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

    12. IPD Sharing Statement

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    Study of Branched-chain Amino Acids in Cancer Cachexia

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