CancerNCT02793531
Anabolic Response Cancer
A study testing Stable isotope amino acid infusion in people with Cancer, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Stable isotope amino acid infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University-CTRAL
College Station, Texas, 77845-4253
About this study
Official title: Assessment of Anabolic Responsiveness to Protein Intake in Advanced Cancer
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.
Read the detailed description
In this study, the Investigators will test the following hypothesis: A protein meal with high EAA levels will stimulate protein anabolism in a dose-dependent way but the exact relationship differs among cancer patients. The primary endpoint will be the extent of stimulation of net whole-body protein synthesis at each level of protein intake in the individual cancer and control subject. This project will provide important clinical information on the anabolic capacity of dietary protein with high EAA levels and the level of protein intake required to become anabolic in cancer patients on an individual bases. In this way, this study will provide preliminary data for the development of individualized nutritional strategies that will stop the process of ongoing muscle loss in cancer patients.
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality protein sip feeding in cancer subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with cancer as compared to healthy controls.
The mechanisms underlying lean tissue loss in cancer remain to be unraveled, which may be because of the complexity of the metabolic alterations that are present when symptoms such as weight loss become obvious. Multiple factors like anorexia and inflammation are present in cancer, all contributing to the loss of lean tissue in these patients by creating a drain on the body protein stores. Previous studies showed that oral supplementation of large amounts of calories in cancer is only partially successful and this indicates that the composition of dietary supplements and meals is important to successfully counteract muscle wasting. Although our previous study supports the concept of supplementing high-quality milk proteins in lung cancer subjects, the dose-response anabolic effects of proteins with high EAA levels are still unclear. Furthermore, there is no insight in the actual protein requirements in cancer. The knowledge gained from this study will benefit our insight in terms of promotion of protein gain after feeding in cancer patients.
- Conditions
- Cancer
- Being tested
- Stable isotope amino acid infusion
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable isotope amino acid infusionOther
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stable isotope amino acid infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in net whole-body protein synthesis
Change in whole-body protein synthesis rate after intake of meal
Measured: 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
Body composition as measured by Dual-Energy X-ray Absorptiometry
Measured: 15 minutes on screening or study day 1
Skeletal muscle strength
handgrip
Measured: on study day 1
Skeletal muscle strength
kin-com 1-leg test
Measured: on study day 1
Respiratory muscle strength
Maximum inhalation and exhalation pressure
Measured: on study day 1
Gut function
Digestion of the stable tracers of amino acid
Measured: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day
Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in state of mood as measured by the Profile of Mood State (POMS)
A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
appetite questionnaire
The subject is asked to rate various aspects of their appetite as relates to overall health
Measured: study day 1
Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)
a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1]
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total and mean words recorded across the three trials) was reported.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Brief-A
a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
diet recall
The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Trail Making Test (TMT)
Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Functional Status
Functional status will be assessed by the Karnofsky Performance Score, a widely used method to assess the functional status of a cancer patient. It describes a patient's functional status as a comprehensive 11-point scale ranging from 0% to 100%.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: low enrollment potential in local community
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793531
- Sponsor's protocol ID
- IRB2015-0460
- Status last verified
- Mar 2018
- First submitted
- 24 May 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anabolic Responsiveness to Protein Intake in Advanced Cancer
- ClinicalTrials.gov ID
- NCT02793531
- Acronym / sponsor ID
- IRB2015-0460
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low enrollment potential in local community
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the Investigators will test the following hypothesis: A protein meal with high EAA levels will stimulate protein anabolism in a dose-dependent way but the exact relationship differs among cancer patients. The primary endpoint will be the extent of stimulation of net whole-body protein synthesis at each level of protein intake in the individual cancer and control subject. This project will provide important clinical information on the anabolic capacity of dietary protein with high EAA levels and the level of protein intake required to become anabolic in cancer patients on an individual bases. In this way, this study will provide preliminary data for the development of individualized nutritional strategies that will stop the process of ongoing muscle loss in cancer patients.
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality protein sip feeding in cancer subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with cancer as compared to healthy controls.
The mechanisms underlying lean tissue loss in cancer remain to be unraveled, which may be because of the complexity of the metabolic alterations that are present when symptoms such as weight loss become obvious. Multiple factors like anorexia and inflammation are present in cancer, all contributing to the loss of lean tissue in these patients by creating a drain on the body protein stores. Previous studies showed that oral supplementation of large amounts of calories in cancer is only partially successful and this indicates that the composition of dietary supplements and meals is important to successfully counteract muscle wasting. Although our previous study supports the concept of supplementing high-quality milk proteins in lung cancer subjects, the dose-response anabolic effects of proteins with high EAA levels are still unclear. Furthermore, there is no insight in the actual protein requirements in cancer. The knowledge gained from this study will benefit our insight in terms of promotion of protein gain after feeding in cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy matched controls | Experimental | Other: Stable isotope amino acid infusionscreening 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. |
| Cancer subjects | Experimental | Other: Stable isotope amino acid infusionscreening 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable isotope amino acid infusionsuch as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline | Other | Cancer subjects, Healthy matched controls |
Primary outcome
Change in net whole-body protein synthesis
Time frame: 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
Change in whole-body protein synthesis rate after intake of meal
17 secondary outcomes
Body Composition
Time frame: 15 minutes on screening or study day 1
Skeletal muscle strength
Time frame: on study day 1
Skeletal muscle strength
Time frame: on study day 1
Respiratory muscle strength
Time frame: on study day 1
Gut function
Time frame: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day
Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
appetite questionnaire
Time frame: study day 1
Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1]
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Brief-A
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
diet recall
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Trail Making Test (TMT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Functional Status
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable isotope amino acid infusion in people with Cancer, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in net whole-body protein synthesis (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.