Cancer Patients Receiving Chemotherapy or ChemoradiotherapyNCT01871350
Nutrition Intervention During Chemotherapy
A study testing Daily intake for 10 weeks (+/- 2 weeks) in people with Cancer Patients Receiving Chemotherapy or Chemoradiotherapy, 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 loss has been reported as a side effect of chemotherapy treatment in cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients Receiving Chemotherapy or Chemoradiotherapy
- What is being tested?
- Daily intake for 10 weeks (+/- 2 weeks)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2013to 3 Nov 2015
- 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
- Diagnosed with cancer
- Scheduled for chemotherapy or chemoradiotherapy
- Ability to sign informed consent
- Age 18y and older
- Ability to lie in supine position for 7 hours
- Healthy male or female according to the investigator's or appointed staff's judgment
- Age 18 years or older
- No diagnosis of cancer
Who cannot join
- Presence of fever within the last 3 days
- BMI > 38 kg/m2 (healthy controls only)
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Use of protein or amino acid containing nutritional supplements within 5 days of first test day
- Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients, Smartfish Nutrifriend or any of its ingredients (Cancer subjects only)
Show all 10Show fewer
- Use of supplements containing EPA+DHA 3 months prior to the first test day
- Any other condition according to the PI or nurse that would interfere with the study or safety of the patient
- Failure to give informed consent
- (Possible) pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
Weight loss and muscle wasting commonly occurs in patients with cancer, negatively influencing their quality of life, treatment response and survival. Weight loss has been reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the consequence of energy imbalance and disturbances in protein metabolism (through different factors linked with chemotherapy), such as reduced caloric and protein intake (partly related to depression), 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 and loss of both fat mass and lean mass in advanced cancer. Depletion of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality.
Gains in muscle mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. Recently, the investigators observed that essential amino acid mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV non-small cell lung cancer. Previous experimental research and clinical studies in cachectic conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states; however, weight and muscle mass gain was not present or minimal. Recent studies examining the effect of fish oil supplementation in relation to chemotherapy have been inconclusive but found potential beneficial effects on physical performance and increased efficacy of first-line chemotherapy in patients with non-small cell lung cancer.
It is the investigators' hypothesis that supplementation with milk protein (containing essential amino acids) carbohydrate (CHO) mixture in combination with fish oil supplementation will target the metabolic alterations in cancer patients receiving chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.
Read the detailed description
For the cancer subjects, the study involves 1 test day prior to a chemotherapy treatment, a 10-week (± 2 weeks) nutritional intervention period at home starting the first day of the chemotherapy treatment, and one test day after this intervention. Chemotherapy in general lasts at least a few months. Recent studies indicate that a 10-week nutritional supplementation period should be long enough to reach significant improvements in nutritional and clinical outcome parameters during chemotherapy. Throughout these 10 weeks the cancer subjects will take the supplements at home. Cancer subjects will be randomly assigned to receive either fish oil or a placebo and protein or a placebo and will take these supplements daily throughout 10 weeks during chemotherapy.
For the healthy subjects, the study will involve one test day (approx. 8 hours).
On the test days, the response to a protein meal will be examined and subjects will receive a mixture of amino acids which are a little bit heavier than normal, called stable isotopes. Subjects will also ingest a sugar drink to assess gut permeability. In total, approximate 120 ml of blood will be drawn on each test day to assess outcome measures. The investigators' will also collect urine over these 8 hours, and cancer subjects are asked to collect a fecal sample the day before the test day.
After completing the nutritional intervention study, cancer subjects will be monitored for up to 6 months via 2 phone calls and through their physician as part of clinical care. Between 6 months and 2 years after completion of the study, information about disease progression (survival) will be obtained from the physician.
- Being tested
- Daily intake for 10 weeks (+/- 2 weeks)
- Keywords
- Cancer, Chemotherapy, Chemo related toxicity, Protein digestion, Fat digestion, Gut function, Glucose absorption, Muscle function
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily intake for 10 weeks (+/- 2 weeks)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Protein and Fish Oil | Experimental | Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g fish oil
High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g fish oil Receives: Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks) |
| Protein | Experimental | Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g olive oil
High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g olive oil Receives: Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks) |
| Placebo | Placebo comparator | Low Dose (FFM <49kg): 12.75g maltodextrin and 6g olive oil
High dose (FFM >49kg): 17.00g maltodextrin and 8g olive oil Receives: Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net whole-body protein synthesis
The acute change in whole-body protein synthesis rate before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: Acutely before and after 4 hours of feeding and the change after 10 weeks of supplementation
Secondary outcomes (15)
Citrulline Rate of appearance
Plasma enrichment of citrulline is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state for 4h on the first test day and the change on the second test day after 10 weeks of supplementation
Glucose absorption
Recovery of 3-O-Methyl-D-glucose in the urine is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: 7 hours during the test day and the change after 10 weeks of supplementation
Gut permeability
Recovery of rhamnose/lactulose in urine is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: 7 hours during the test day and the change after 10 weeks of supplementation
Skeletal and respiratory muscle strength
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls on test day 1. The cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Cognitive function
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism. The cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: On the first test day and the change on the second test day after 10 weeks of supplementation
Fatty acid digestion after feeding
Enrichment in palmitic acid and tripalmitin fatty acids in plasma in response to a meal is measured on the first test day in for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: Acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Protein digestion after feeding
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina in response to a meal is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: Acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Whole body collagen breakdown rate
Hydroxyproline enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Tryptophan turnover rate
Tryptophan enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Insulin response to feeding
The acute change in insulin levels before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Fat-free mass
Fat free mass is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In postabsorptive state on test day 1 and the difference on test day 2, after 10 weeks of supplementation
Myofibrillar protein breakdown rate
The acute change 3-methylhistidine enrichment in plasma before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Glycine rate of appearance
Glycine enrichment in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Taurine turnover rate
Enrichment of taurine in plasma is measured on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Measured: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
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: On the first test day and the change on the second test day after 10 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study start26 Apr 2013
- Primary completion3 Nov 2015
- Study completion3 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Patients Receiving Chemotherapy or ChemoradiotherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 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
- Investigators
- Marielle PKJ Engelen, PhD, Principal investigator, Texas A&M Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871350
- Sponsor's protocol ID
- 2012-0504
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2013
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
- ClinicalTrials.gov ID
- NCT01871350
- Acronym / sponsor ID
- 2012-0504
- Keywords
- Cancer, Chemotherapy, Chemo related toxicity, Protein digestion, Fat digestion, Gut function, Glucose absorption, Muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 26 Apr 2013 (actual)
- Primary completion
- 3 Nov 2015 (actual)
- Study completion
- 3 Nov 2015 (actual)
- First posted
- 6 Jun 2013 (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 loss has been reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the consequence of energy imbalance and disturbances in protein metabolism (through different factors linked with chemotherapy), such as reduced caloric and protein intake (partly related to depression), 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 and loss of both fat mass and lean mass in advanced cancer. Depletion of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality.
Gains in muscle mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. Recently, the investigators observed that essential amino acid mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV non-small cell lung cancer. Previous experimental research and clinical studies in cachectic conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states; however, weight and muscle mass gain was not present or minimal. Recent studies examining the effect of fish oil supplementation in relation to chemotherapy have been inconclusive but found potential beneficial effects on physical performance and increased efficacy of first-line chemotherapy in patients with non-small cell lung cancer.
It is the investigators' hypothesis that supplementation with milk protein (containing essential amino acids) carbohydrate (CHO) mixture in combination with fish oil supplementation will target the metabolic alterations in cancer patients receiving chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.
Detailed description
For the cancer subjects, the study involves 1 test day prior to a chemotherapy treatment, a 10-week (± 2 weeks) nutritional intervention period at home starting the first day of the chemotherapy treatment, and one test day after this intervention. Chemotherapy in general lasts at least a few months. Recent studies indicate that a 10-week nutritional supplementation period should be long enough to reach significant improvements in nutritional and clinical outcome parameters during chemotherapy. Throughout these 10 weeks the cancer subjects will take the supplements at home. Cancer subjects will be randomly assigned to receive either fish oil or a placebo and protein or a placebo and will take these supplements daily throughout 10 weeks during chemotherapy.
For the healthy subjects, the study will involve one test day (approx. 8 hours).
On the test days, the response to a protein meal will be examined and subjects will receive a mixture of amino acids which are a little bit heavier than normal, called stable isotopes. Subjects will also ingest a sugar drink to assess gut permeability. In total, approximate 120 ml of blood will be drawn on each test day to assess outcome measures. The investigators' will also collect urine over these 8 hours, and cancer subjects are asked to collect a fecal sample the day before the test day.
After completing the nutritional intervention study, cancer subjects will be monitored for up to 6 months via 2 phone calls and through their physician as part of clinical care. Between 6 months and 2 years after completion of the study, information about disease progression (survival) will be obtained from the physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein and Fish Oil | Experimental | Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g fish oil High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g fish oil |
| Protein | Experimental | Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)Low Dose (FFM <49kg): 30.00g milk protein + 12.75g maltodextrin and 6g olive oil High dose (FFM >49kg): 40.00g milk protein + 17.00g maltodextrin and 8g olive oil |
| Placebo | Placebo comparator | Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)Low Dose (FFM <49kg): 12.75g maltodextrin and 6g olive oil High dose (FFM >49kg): 17.00g maltodextrin and 8g olive oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with cancer
- Scheduled for chemotherapy or chemoradiotherapy
- Ability to sign informed consent
- Age 18y and older
- Ability to lie in supine position for 7 hours
Key exclusion criteria (10 listed)
- Presence of fever within the last 3 days
- BMI > 38 kg/m2 (healthy controls only)
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Use of protein or amino acid containing nutritional supplements within 5 days of first test day
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 |
|---|---|---|
| Daily intake for 10 weeks (+/- 2 weeks) | Dietary supplement | Placebo, Protein, Protein and Fish Oil |
Primary outcome
Net whole-body protein synthesis
Time frame: Acutely before and after 4 hours of feeding and the change after 10 weeks of supplementation
The acute change in whole-body protein synthesis rate before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 10 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
15 secondary outcomes
Citrulline Rate of appearance
Time frame: In the postabsorptive state for 4h on the first test day and the change on the second test day after 10 weeks of supplementation
Glucose absorption
Time frame: 7 hours during the test day and the change after 10 weeks of supplementation
Gut permeability
Time frame: 7 hours during the test day and the change after 10 weeks of supplementation
Skeletal and respiratory muscle strength
Time frame: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Cognitive function
Time frame: On the first test day and the change on the second test day after 10 weeks of supplementation
Fatty acid digestion after feeding
Time frame: Acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Protein digestion after feeding
Time frame: Acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Whole body collagen breakdown rate
Time frame: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Tryptophan turnover rate
Time frame: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Insulin response to feeding
Time frame: Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Fat-free mass
Time frame: In postabsorptive state on test day 1 and the difference on test day 2, after 10 weeks of supplementation
Myofibrillar protein breakdown rate
Time frame: Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation
Glycine rate of appearance
Time frame: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Taurine turnover rate
Time frame: In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation
Functional Status
Time frame: On the first test day and the change on the second test day after 10 weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
Related trials for Cancer Patients Receiving Chemotherapy or Chemoradiotherapy
Active, not recruitingPhase 2
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Oral Mucositis
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.
Marielle PKJ Engelen, PhD principal investigator
Texas A&M Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily intake for 10 weeks (+/- 2 weeks) in people with Cancer Patients Receiving Chemotherapy or Chemoradiotherapy, 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 8 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: finished, as of the sponsor's last update on 30 Sep 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Net whole-body protein synthesis (time frame: Acutely before and after 4 hours of feeding and the change after 10 weeks of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871350, which also lists 1 linked publication.
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 30 Sep 2025.