Cancer Patients Receiving Chemotherapy or Chemoradiotherapy Clinical Trial
Official title:
Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
| Verified date | April 2019 |
| Source | Texas A&M University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 31 |
| Est. completion date | October 2021 |
| Est. primary completion date | October 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria cancer subjects: - 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 Inclusion criteria healthy subjects: - Healthy male or female according to the investigator's or appointed staff's judgment - Age 18 years or older - No diagnosis of cancer Exclusion Criteria - 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) - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas A&M University | College Station | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Texas A&M University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Acutely before and after 4 hours of feeding and the change after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state for 4h on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | 7 hours during the test day and the change after 10 weeks of supplementation | |
| Secondary | 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. | 7 hours during the test day and the change after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | On the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | Acutely after 4 hours of feeding and the change after 10 weeks of supplementation | |
| Secondary | 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. | Acutely after 4 hours of feeding and the change after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation | |
| Secondary | 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. | In postabsorptive state on test day 1 and the difference on test day 2, after 10 weeks of supplementation | |
| Secondary | 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. | Before and acutely after 4 hours of feeding and the change after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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. | In the postabsorptive state on the first test day and the change on the second test day after 10 weeks of supplementation | |
| Secondary | 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%. | On the first test day and the change on the second test day after 10 weeks of supplementation |