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NCT01871350 · ClinicalTrials.gov registry record · NA
Nutrition Intervention During Chemotherapy
A NA study of Cancer Patients Receiving Chemotherapy or Chemoradiotherapy, sponsored by Texas A&M University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01871350 is a NA study of Cancer Patients Receiving Chemotherapy or Chemoradiotherapy that has completed, run by Texas A&M University. The registered enrollment target is 31 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01871350, a NA study of Cancer Patients Receiving Chemotherapy or Chemoradiotherapy, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study 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. 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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Daily intake for 10 weeks (+/- 2 weeks)
Study Locations (1)
Texas
- Texas A&M University - College Station
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-04-26 |
| Est. Completion | 2015-11-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01871350
The ClinicalTrials.gov registry entry for NCT01871350 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cancer Patients Receiving Chemotherapy or Chemoradiotherapy appearing as the primary indexed condition, and to 1 intervention - of which Daily intake for 10 weeks (+/- 2 weeks) is the first listed.
NCT01871350 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01871350 about?
NCT01871350 is a clinical study titled "Nutrition Intervention During Chemotherapy". 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 dis...
What is the current status of trial NCT01871350?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2013-04-26. Estimated completion is 2015-11-03.
What conditions does trial NCT01871350 study?
This clinical trial studies the following conditions: Cancer Patients Receiving Chemotherapy or Chemoradiotherapy.
What interventions are being tested in trial NCT01871350?
The interventions under investigation include: Daily intake for 10 weeks (+/- 2 weeks) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01871350?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01871350 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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