Cancer Patients Receiving Chemotherapy or Chemoradiotherapy Clinical Trial
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 modiļ¬cations 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.
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.
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