Gastric CancerPhase 3NCT01048463
Effect of Enteral Nutrition Rich in Eicosapentaenoic Acid (EPA) on Patients Receiving Chemotherapy for GI Tumor
A Phase 3 study testing Nutriall, LDEPA and HDEPA in people with Gastric Cancer and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Chemotherapy
- What is being tested?
- Nutriall, LDEPA and HDEPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Jan 2012
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The cases have undergone radical excision on gastric cancer or colorectal cancer.
- Without contraindication for chemotherapy.
- Eligible for postoperative adjuvant XELOX chemotherapy.
- Capable of taking in food or drug orally.
- Without severe absorption dysfunction
- Able and willing to give written, informed consent
Who cannot join
- Comorbidities: diseases of hematology or immunology system; hepatic or renal dysfunction; metabolic diseases.
- BMI>35kg/m2
- Life expectancy≤3mo
- The chemotherapy treatment is palliative.
- The patient has received radiotherapy or neoadjuvant chemotherapy prior to the operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Han-ping Shi, MD, PhD, 86-0-13802741263, shihp38@hotmail.com
About this study
Official title: Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer
Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic status, quality of life, and reduce chemotherapy related side effects of these patients.
Read the detailed description
Chemotherapy is indispensible for patients suffering from advanced gastric or colorectal cancer, and also the main therapy for those with end-stage tumor. However, incidence of malnutrition during chemotherapy was reported as high as 60%. The mechanisms include anatomy modification of digestive tract, side effects of chemotherapy such as anorexia, nausea, vomiting, and inflammatory factors generated or induced by the tumor. Malnutrition may lead to discontinuation of the therapy, compromise of the anti-cancer effect, increase of toxicity and mortality. 20%-40% of patients with end-stage tumor ultimately died from malnutrition.
EPA (Eicosapentaenoic acid, molecular formula C20H30O2) belongs to ω-3 polyunsaturated fatty acid (ω-3 PUFA). EPA is one of the main constituent of fish oil. EPA decreases LPS-stimulated macrophage production of TNF-α, IL-1β, IL-6, and human B lymphocytes production of IL-10, TNF-α, IFN-γ. EPA can suppress cancer induced lipolysis, and enhanced the inhibitory effect of 5-Fu over cancer cell proliferation. However, cancer patients are always lack of EPA.
Nutriall is a sort of non-elemental diet. The kind of powder is produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE. For this enteral nutrition preparation, there have been evidences of protective effects on nutritional status during chemotherapy on lung cancer. However, this kind of preparation does not contain EPA.
Up to date, there has been no RCT which testified whether therapeutic dosage of EPA plus enteral nutrition has combined effects on patients receiving chemotherapy. The investigators choose nutriall as basic nutritional support agent during chemotherapy, and give patients different dosage of EPA. Nutritional and immunologic status, quality of life and side effects of chemotherapy are recorded to evaluate whether EPA can improve outcome of these patients. Through this study the investigators may also optimize the dose of EPA for patients receiving chemotherapy on gastric/colorectal cancer.
- Conditions
- Gastric Cancer, Colorectal Cancer, Chemotherapy
- Being tested
- Nutriall, LDEPA, Placebo, HDEPA, Chemotherapy
- Keywords
- gastric cancer, colorectal cancer, chemotherapy, eicosapentaenoic acid, enteral nutrition
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriallDrug
Also called Complete Enteral Nutrition Emulsion for cancer patients
The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
LDEPADrug
Also called Eicosapentaenoic acid
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.125g of EPA and 0.125g of olive oil. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
PlaceboDrug
Also called Gelatin capsule
The subjects take in 24 pils of gelatin capsule (each contains 0.25g of olive oil, provided by nutritional department of our institute) per day. The treatment lasts for 21d.
HDEPADrug
Also called Eicosapentaenoic acid
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.25g of EPA. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
ChemotherapyDrug
Also called XELOX chemotherapy
Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)
| Study group | Role | What they receive |
|---|---|---|
| EN | Placebo comparator | The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX. Receives: Drug: Nutriall; Drug: Placebo; Drug: Chemotherapy |
| ENLDEPA | Experimental | The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX. Receives: Drug: Nutriall; Drug: LDEPA; Drug: Chemotherapy |
| ENHDPEA | Experimental | The subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX. Receives: Drug: Nutriall; Drug: HDEPA; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of proalbumin
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Secondary outcomes (19)
Weight in light clothing
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Height and BMI
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
mid upper arm circumference and triceps skinfold thickness
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat ratio and fat mass
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat-free mass, muscle mass and muscle function
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
CD distribution of T cells
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of immunoglobulin
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of cytokines
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of Cortisol
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of transferrin
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of ALT and AST
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of creatine and BUN
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of total triglyceride, total cholesterol, LDL, HDL
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of EPA intake
Measured: The whole experiment period
Records of chemotherapy-associated side effects
Measured: The whole experiment period
Serum level of albumin
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of CEA, CA125, CA199
Measured: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of Nutriall intake
Measured: The whole experiment period
Records of food intake
Measured: The middle 3 days of the whole experiment period (day10, day11, day12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanqing Sun, Sun Yat-sen University
- Investigators
- Huilian Zhu, MD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048463
- Sponsor's protocol ID
- EPACT
- Status last verified
- Oct 2011
- First submitted
- 12 Jan 2010
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barber MD, Fearon KC. Tolerance and incorporation of a high-dose eicosapentaenoic acid diester emulsion by patients with pancreatic cancer cachexia. Lipids. 2001 Apr;36(4):347-51. doi: 10.1007/s11745-001-0726-4.
PubMed 11383684Bayram I, Erbey F, Celik N, Nelson JL, Tanyeli A. The use of a protein and energy dense eicosapentaenoic acid containing supplement for malignancy-related weight loss in children. Pediatr Blood Cancer. 2009 May;52(5):571-4. doi: 10.1002/pbc.21852.
PubMed 19090549Calviello G, Di Nicuolo F, Serini S, Piccioni E, Boninsegna A, Maggiano N, Ranelletti FO, Palozza P. Docosahexaenoic acid enhances the susceptibility of human colorectal cancer cells to 5-fluorouracil. Cancer Chemother Pharmacol. 2005 Jan;55(1):12-20. doi: 10.1007/s00280-004-0846-6. Epub 2004 Sep 10.
PubMed 15365767Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139.
PubMed 2071835Elia M, Van Bokhorst-de van der Schueren MA, Garvey J, Goedhart A, Lundholm K, Nitenberg G, Stratton RJ. Enteral (oral or tube administration) nutritional support and eicosapentaenoic acid in patients with cancer: a systematic review. Int J Oncol. 2006 Jan;28(1):5-23. doi: 10.3892/ijo.28.1.5.
PubMed 16327975Gorjao R, Azevedo-Martins AK, Rodrigues HG, Abdulkader F, Arcisio-Miranda M, Procopio J, Curi R. Comparative effects of DHA and EPA on cell function. Pharmacol Ther. 2009 Apr;122(1):56-64. doi: 10.1016/j.pharmthera.2009.01.004. Epub 2009 Feb 12.
PubMed 19318040Pratt VC, Watanabe S, Bruera E, Mackey J, Clandinin MT, Baracos VE, Field CJ. Plasma and neutrophil fatty acid composition in advanced cancer patients and response to fish oil supplementation. Br J Cancer. 2002 Dec 2;87(12):1370-8. doi: 10.1038/sj.bjc.6600659.
PubMed 12454764Read JA, Beale PJ, Volker DH, Smith N, Childs A, Clarke SJ. Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Support Care Cancer. 2007 Mar;15(3):301-7. doi: 10.1007/s00520-006-0153-3. Epub 2006 Oct 5.
PubMed 17021855Read JA, Crockett N, Volker DH, MacLennan P, Choy ST, Beale P, Clarke SJ. Nutritional assessment in cancer: comparing the Mini-Nutritional Assessment (MNA) with the scored Patient-Generated Subjective Global Assessment (PGSGA). Nutr Cancer. 2005;53(1):51-6. doi: 10.1207/s15327914nc5301_6.
PubMed 16351506Russell ST, Tisdale MJ. Effect of eicosapentaenoic acid (EPA) on expression of a lipid mobilizing factor in adipose tissue in cancer cachexia. Prostaglandins Leukot Essent Fatty Acids. 2005 Jun;72(6):409-14. doi: 10.1016/j.plefa.2005.03.002.
PubMed 15899583Wang ZD, Peng JS, Chen S, Huang ZM, Huang L. [Effects of perioperative enteral immunonutrition on nutritional status, immunity and inflammatory response of elderly patients]. Zhonghua Yi Xue Za Zhi. 2006 May 30;86(20):1410-3. Chinese.
PubMed 16796925Yam D, Peled A, Shinitzky M. Suppression of tumor growth and metastasis by dietary fish oil combined with vitamins E and C and cisplatin. Cancer Chemother Pharmacol. 2001;47(1):34-40. doi: 10.1007/s002800000205.
PubMed 11221959Zhong HJ, Ying JE, Ma SL. [Effect of Supportan on nutritional status and immune function of late-staged gastric cancer patients undergoing chemotherapy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2006 Sep;9(5):405-8. Chinese.
PubMed 17043961
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01048463
- Acronym / sponsor ID
- EPACT
- Conditions
- Gastric Cancer, Colorectal Cancer, Chemotherapy
- Keywords
- gastric cancer, colorectal cancer, chemotherapy, eicosapentaenoic acid, enteral nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 13 Jan 2010 (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.
Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic status, quality of life, and reduce chemotherapy related side effects of these patients.
Detailed description
Chemotherapy is indispensible for patients suffering from advanced gastric or colorectal cancer, and also the main therapy for those with end-stage tumor. However, incidence of malnutrition during chemotherapy was reported as high as 60%. The mechanisms include anatomy modification of digestive tract, side effects of chemotherapy such as anorexia, nausea, vomiting, and inflammatory factors generated or induced by the tumor. Malnutrition may lead to discontinuation of the therapy, compromise of the anti-cancer effect, increase of toxicity and mortality. 20%-40% of patients with end-stage tumor ultimately died from malnutrition.
EPA (Eicosapentaenoic acid, molecular formula C20H30O2) belongs to ω-3 polyunsaturated fatty acid (ω-3 PUFA). EPA is one of the main constituent of fish oil. EPA decreases LPS-stimulated macrophage production of TNF-α, IL-1β, IL-6, and human B lymphocytes production of IL-10, TNF-α, IFN-γ. EPA can suppress cancer induced lipolysis, and enhanced the inhibitory effect of 5-Fu over cancer cell proliferation. However, cancer patients are always lack of EPA.
Nutriall is a sort of non-elemental diet. The kind of powder is produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE. For this enteral nutrition preparation, there have been evidences of protective effects on nutritional status during chemotherapy on lung cancer. However, this kind of preparation does not contain EPA.
Up to date, there has been no RCT which testified whether therapeutic dosage of EPA plus enteral nutrition has combined effects on patients receiving chemotherapy. The investigators choose nutriall as basic nutritional support agent during chemotherapy, and give patients different dosage of EPA. Nutritional and immunologic status, quality of life and side effects of chemotherapy are recorded to evaluate whether EPA can improve outcome of these patients. Through this study the investigators may also optimize the dose of EPA for patients receiving chemotherapy on gastric/colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EN | Placebo comparator | Drug: Nutriall, Drug: Placebo, Drug: ChemotherapyThe subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX. |
| ENLDEPA | Experimental | Drug: Nutriall, Drug: LDEPA, Drug: ChemotherapyThe subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX. |
| ENHDPEA | Experimental | Drug: Nutriall, Drug: HDEPA, Drug: ChemotherapyThe subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The cases have undergone radical excision on gastric cancer or colorectal cancer.
- Without contraindication for chemotherapy.
- Eligible for postoperative adjuvant XELOX chemotherapy.
- Capable of taking in food or drug orally.
- Without severe absorption dysfunction
Key exclusion criteria (5 listed)
- Comorbidities: diseases of hematology or immunology system; hepatic or renal dysfunction; metabolic diseases.
- BMI>35kg/m2
- Life expectancy≤3mo
- The chemotherapy treatment is palliative.
- The patient has received radiotherapy or neoadjuvant chemotherapy prior to the operation.
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 |
|---|---|---|
| NutriallAlso: Complete Enteral Nutrition Emulsion for cancer patientsThe subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. | Drug | EN, ENHDPEA, ENLDEPA |
| LDEPAAlso: Eicosapentaenoic acidThe subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.125g of EPA and 0.125g of olive oil. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d. | Drug | ENLDEPA |
| PlaceboAlso: Gelatin capsuleThe subjects take in 24 pils of gelatin capsule (each contains 0.25g of olive oil, provided by nutritional department of our institute) per day. The treatment lasts for 21d. | Drug | EN |
| HDEPAAlso: Eicosapentaenoic acidThe subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.25g of EPA. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d. | Drug | ENHDPEA |
| ChemotherapyAlso: XELOX chemotherapyOxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX) | Drug | EN, ENHDPEA, ENLDEPA |
Primary outcome
Serum level of proalbumin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
19 secondary outcomes
Weight in light clothing
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Height and BMI
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
mid upper arm circumference and triceps skinfold thickness
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat ratio and fat mass
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat-free mass, muscle mass and muscle function
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
CD distribution of T cells
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of immunoglobulin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of cytokines
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of Cortisol
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of transferrin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of ALT and AST
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of creatine and BUN
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of total triglyceride, total cholesterol, LDL, HDL
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of EPA intake
Time frame: The whole experiment period
Records of chemotherapy-associated side effects
Time frame: The whole experiment period
Serum level of albumin
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of CEA, CA125, CA199
Time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of Nutriall intake
Time frame: The whole experiment period
Records of food intake
Time frame: The middle 3 days of the whole experiment period (day10, day11, day12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Background: PubMed 11383684Barber MD, Fearon KC. Tolerance and incorporation of a high-dose eicosapentaenoic acid diester emulsion by patients with pancreatic cancer cachexia. Lipids. 2001 Apr;36(4):347-51. doi: 10.1007/s11745-001-0726-4.
- Background: PubMed 19090549Bayram I, Erbey F, Celik N, Nelson JL, Tanyeli A. The use of a protein and energy dense eicosapentaenoic acid containing supplement for malignancy-related weight loss in children. Pediatr Blood Cancer. 2009 May;52(5):571-4. doi: 10.1002/pbc.21852.
- Background: PubMed 15365767Calviello G, Di Nicuolo F, Serini S, Piccioni E, Boninsegna A, Maggiano N, Ranelletti FO, Palozza P. Docosahexaenoic acid enhances the susceptibility of human colorectal cancer cells to 5-fluorouracil. Cancer Chemother Pharmacol. 2005 Jan;55(1):12-20. doi: 10.1007/s00280-004-0846-6. Epub 2004 Sep 10.
- Background: PubMed 2071835Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139.
- Background: PubMed 16327975Elia M, Van Bokhorst-de van der Schueren MA, Garvey J, Goedhart A, Lundholm K, Nitenberg G, Stratton RJ. Enteral (oral or tube administration) nutritional support and eicosapentaenoic acid in patients with cancer: a systematic review. Int J Oncol. 2006 Jan;28(1):5-23. doi: 10.3892/ijo.28.1.5.
- Background: PubMed 19318040Gorjao R, Azevedo-Martins AK, Rodrigues HG, Abdulkader F, Arcisio-Miranda M, Procopio J, Curi R. Comparative effects of DHA and EPA on cell function. Pharmacol Ther. 2009 Apr;122(1):56-64. doi: 10.1016/j.pharmthera.2009.01.004. Epub 2009 Feb 12.
- Background: PubMed 12454764Pratt VC, Watanabe S, Bruera E, Mackey J, Clandinin MT, Baracos VE, Field CJ. Plasma and neutrophil fatty acid composition in advanced cancer patients and response to fish oil supplementation. Br J Cancer. 2002 Dec 2;87(12):1370-8. doi: 10.1038/sj.bjc.6600659.
- Background: PubMed 17021855Read JA, Beale PJ, Volker DH, Smith N, Childs A, Clarke SJ. Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Support Care Cancer. 2007 Mar;15(3):301-7. doi: 10.1007/s00520-006-0153-3. Epub 2006 Oct 5.
- Background: PubMed 16351506Read JA, Crockett N, Volker DH, MacLennan P, Choy ST, Beale P, Clarke SJ. Nutritional assessment in cancer: comparing the Mini-Nutritional Assessment (MNA) with the scored Patient-Generated Subjective Global Assessment (PGSGA). Nutr Cancer. 2005;53(1):51-6. doi: 10.1207/s15327914nc5301_6.
- Background: PubMed 15899583Russell ST, Tisdale MJ. Effect of eicosapentaenoic acid (EPA) on expression of a lipid mobilizing factor in adipose tissue in cancer cachexia. Prostaglandins Leukot Essent Fatty Acids. 2005 Jun;72(6):409-14. doi: 10.1016/j.plefa.2005.03.002.
- Background: PubMed 16796925Wang ZD, Peng JS, Chen S, Huang ZM, Huang L. [Effects of perioperative enteral immunonutrition on nutritional status, immunity and inflammatory response of elderly patients]. Zhonghua Yi Xue Za Zhi. 2006 May 30;86(20):1410-3. Chinese.
- Background: PubMed 11221959Yam D, Peled A, Shinitzky M. Suppression of tumor growth and metastasis by dietary fish oil combined with vitamins E and C and cisplatin. Cancer Chemother Pharmacol. 2001;47(1):34-40. doi: 10.1007/s002800000205.
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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.
Huilian Zhu, MD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutriall, LDEPA and HDEPA in people with Gastric Cancer and Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Oct 2011. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Fang, MD (86-0-13539951951, fangshi2008@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of proalbumin (time frame: The starting and ending day of the experiment for a certain subject (day1 and day21)). 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 NCT01048463, which also lists 13 linked publications.
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 6 Oct 2011.