Anabolic Response Cancer

NCT02793531 | Withdrawn

• 1 other identifier: IRB2015-0460
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss and muscle wasting commonly occurs in patients with cancer, negatively influencing their quality of life, treatment response and survival. Weight changes in patients with cancer may be the consequence of energy imbalance and disturbances in protein metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This results in body composition modifications in favor of fat gain and/or lean body mass loss in early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass has been found. Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein was able to stimulate whole-body protein anabolism equally and effectively in weight-losing patients with lung cancer. This indicates the high potential of proteins with high essential amino acids as therapeutic agents to increase muscle mass in these patients. However, the dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can differ among patients. Therefore, the Investigators would like to study the effects of several dosages of a protein with high essential amino acid levels, administered by sip feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy older adults. Furthermore, the individual protein requirements of cancer patients may be established as this is the cornerstone of nutritional support. Specifically to establish 'the anabolic threshold', when protein breakdown equals synthesis and the response and the relation between protein intake and net protein synthesis are critical.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Change in net whole-body protein synthesis

  Change in whole-body protein synthesis rate after intake of meal

  0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min

Secondary Outcomes (17)

• Body Composition

  15 minutes on screening or study day 1

• Skeletal muscle strength

  on study day 1

• Skeletal muscle strength

  on study day 1

• Respiratory muscle strength

  on study day 1

• Gut function

  In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day

Study Arms (2)

Healthy matched controls

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding. study day: muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.

Other: Stable isotope amino acid infusion

Cancer subjects

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding. study day: muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.

Other: Stable isotope amino acid infusion

Interventions

Stable isotope amino acid infusion OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Cancer subjects; Healthy matched controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Ability to lie in supine or elevated position for 8 hours
• Diagnosed with stage III/IV cancer (all solid tumors excluding breast or prostate)
• No chemotherapy/radiotherapy within past month prior to the study day
• Willingness and ability to comply with the protocol
• Healthy male or female according to the investigator's or appointed staff's judgment
• Age 18 years or older
• Ability to lay in supine or elevated position for 8 hours
• No diagnosis of cancer
• No diagnosis of diabetes
• Willingness and ability to comply with the protocol

You may not qualify if:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
• Presence of fever within the last 3 days
• Untreated metabolic diseases including hepatic or renal disorder
• Presence of acute illness or metabolically unstable chronic illness
• BMI of \< 18.5 or ≥ 35 kg/m2 (for healthy control group only)
• Dietary or lifestyle characteristics: Current alcohol or drug abuse, Use of protein or amino acid containing nutritional supplements within 5 days prior to the study day
• Known allergy to milk or milk products
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• (Possible) pregnancy
• Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77845-4253, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)