Lung CancerPhase 2/3NCT01048970
Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer
A Phase 2/3 study testing Nutritional Assessment and EPA-DHA arm in people with Lung Cancer, run by National Institute of Cancerología at 2 sites in Mexico.
Trial summary
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient quality of life, response rate to chemotherapy and survival. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nutritional Assessment and EPA-DHA arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesMexico
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 2/3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathology diagnosis of stage IIIB or IV lung cancer.
- Patients who will received paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 chemotherapy treatment each 3 weeks.
- ECOG < 2.
- Hepatic, nephrotic and hematology laboratories in normal ranges.
Who cannot join
- Patients who do not accept to participate.
- Patients who have been received chemotherapy treatment.
- Patients with current nutritional assessment and/or nutritional supplements intake.
- Patients with poor performance status.
- Pregnant or lactating women.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
National Institute of Cancerologia
Mexico City, Mexico City, 14080
Oscar Arrieta, MD, (+52) (55) 5628-0400 ext. 832, ogar@servidor.unam.mx
Karla Sanchez, MsC, (+52) (55) 5414-7200 ext. 4216, ksanchez@medicasur.org.mx
- Recruiting
National Institute of Cancerología
Mexico City, Mexico City, 14080
Oscar Arrieta
About this study
Official title: A Prospective Randomized Trial: Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement on the Nutritional and Inflammatory Status, Quality of Life, Toxicity and Response Rate to First-line Chemotherapy in Patients With Advanced Lung Cancer
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient quality of life, response rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake, inflammatory response and quality of life in first-line chemotherapy patients with advanced lung cancer.
Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement or nutritional assessment one week prior to treatment until completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance analysis (BIA). Quality of life, dietary intake will be assessed with validate questionnaires. All data is going to be collected in a database for further blind analysis. Written informed consent will be collected from all patients.
Read the detailed description
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient quality of life, response rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake, inflammatory response and quality of life in first-line chemotherapy patients with advanced lung cancer.
Hypothesis: Lung cancer patients who received EPA and DHA containing oral supplement will have a lower frequency of weight loss, rate of adverse effects to chemotherapy and inflammatory response, improving quality of life, response rate to chemotherapy compared with patients who received nutritional assessment.
Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement or nutritional assessment one week prior to treatment until completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance analysis (BIA). Quality of life, dietary intake will be assessed with validate questionnaires. All data is going to be collected in a database for further blind analysis. Written informed consent will be collected from all patients.
- Conditions
- Lung Cancer
- Being tested
- Nutritional Assessment, EPA-DHA arm
- Keywords
- Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response
- Medical subject headings
- Lung Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional AssessmentOther
Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
EPA-DHA armDietary supplement
Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Patients will receive nutritional assessment one week prior to treatment until completing two cycles Receives: Other: Nutritional Assessment |
| EPA-DHA arm | Experimental | Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy Receives: Dietary Supplement: EPA-DHA arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory response
Measured: 12 months
Response rate to chemotherapy
Measured: 1 year
Quality of life
Measured: 1 year
Nutritional status
Measured: 1 year
Secondary outcomes (1)
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Collaborators
- Abbott
- Investigators
- Oscar Arrieta, MD, Principal investigator, National Institute of Cancerología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048970
- Sponsor's protocol ID
- INCAN/CC/330/09
- Other IDs
- CA171/CB/558/09
- Status last verified
- Jan 2010
- First submitted
- 9 Jan 2010
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Fearon KC, Von Meyenfeldt MF, Moses AG, Van Geenen R, Roy A, Gouma DJ, Giacosa A, Van Gossum A, Bauer J, Barber MD, Aaronson NK, Voss AC, Tisdale MJ. Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial. Gut. 2003 Oct;52(10):1479-86. doi: 10.1136/gut.52.10.1479.
PubMed 12970142Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37.
PubMed 19175932Dewey A, Baughan C, Dean T, Higgins B, Johnson I. Eicosapentaenoic acid (EPA, an omega-3 fatty acid from fish oils) for the treatment of cancer cachexia. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD004597. doi: 10.1002/14651858.CD004597.pub2.
PubMed 17253515Sanchez-Lara K, Turcott JG, Juarez-Hernandez E, Nunez-Valencia C, Villanueva G, Guevara P, De la Torre-Vallejo M, Mohar A, Arrieta O. Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: randomised trial. Clin Nutr. 2014 Dec;33(6):1017-23. doi: 10.1016/j.clnu.2014.03.006. Epub 2014 Apr 4.
PubMed 24746976
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial: Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement on the Nutritional and Inflammatory Status, Quality of Life, Toxicity and Response Rate to First-line Chemotherapy in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT01048970
- Acronym / sponsor ID
- INCAN/CC/330/09
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Collaborators
- Abbott
- Study start
- Oct 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 14 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.
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient quality of life, response rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake, inflammatory response and quality of life in first-line chemotherapy patients with advanced lung cancer.
Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement or nutritional assessment one week prior to treatment until completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance analysis (BIA). Quality of life, dietary intake will be assessed with validate questionnaires. All data is going to be collected in a database for further blind analysis. Written informed consent will be collected from all patients.
Detailed description
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient quality of life, response rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids with nutritional assessment for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary intake, inflammatory response and quality of life in first-line chemotherapy patients with advanced lung cancer.
Hypothesis: Lung cancer patients who received EPA and DHA containing oral supplement will have a lower frequency of weight loss, rate of adverse effects to chemotherapy and inflammatory response, improving quality of life, response rate to chemotherapy compared with patients who received nutritional assessment.
Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement or nutritional assessment one week prior to treatment until completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two courses of chemotherapy. Phase angle and body composition will be measured using Bioimpedance analysis (BIA). Quality of life, dietary intake will be assessed with validate questionnaires. All data is going to be collected in a database for further blind analysis. Written informed consent will be collected from all patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: Nutritional AssessmentPatients will receive nutritional assessment one week prior to treatment until completing two cycles |
| EPA-DHA arm | Experimental | Dietary Supplement: EPA-DHA armPatients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathology diagnosis of stage IIIB or IV lung cancer.
- Patients who will received paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 chemotherapy treatment each 3 weeks.
- ECOG < 2.
- Hepatic, nephrotic and hematology laboratories in normal ranges.
Key exclusion criteria (5 listed)
- Patients who do not accept to participate.
- Patients who have been received chemotherapy treatment.
- Patients with current nutritional assessment and/or nutritional supplements intake.
- Patients with poor performance status.
- Pregnant or lactating women.
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 |
|---|---|---|
| Nutritional AssessmentPatients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy | Other | Control arm |
| EPA-DHA armPatients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy | Dietary supplement | EPA-DHA arm |
Primary outcome
Inflammatory response
Time frame: 12 months
Response rate to chemotherapy
Time frame: 1 year
Quality of life
Time frame: 1 year
Nutritional status
Time frame: 1 year
1 secondary outcome
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Background: PubMed 12970142Fearon KC, Von Meyenfeldt MF, Moses AG, Van Geenen R, Roy A, Gouma DJ, Giacosa A, Van Gossum A, Bauer J, Barber MD, Aaronson NK, Voss AC, Tisdale MJ. Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial. Gut. 2003 Oct;52(10):1479-86. doi: 10.1136/gut.52.10.1479.
- Background: PubMed 19175932Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37.
- Background: PubMed 17253515Dewey A, Baughan C, Dean T, Higgins B, Johnson I. Eicosapentaenoic acid (EPA, an omega-3 fatty acid from fish oils) for the treatment of cancer cachexia. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD004597. doi: 10.1002/14651858.CD004597.pub2.
- Derived from this study: PubMed 24746976Sanchez-Lara K, Turcott JG, Juarez-Hernandez E, Nunez-Valencia C, Villanueva G, Guevara P, De la Torre-Vallejo M, Mohar A, Arrieta O. Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: randomised trial. Clin Nutr. 2014 Dec;33(6):1017-23. doi: 10.1016/j.clnu.2014.03.006. Epub 2014 Apr 4.
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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.
Oscar Arrieta, MD principal investigator
National Institute of Cancerología
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nutritional Assessment and EPA-DHA arm in people with Lung Cancer, run by National Institute of Cancerología at 2 sites in Mexico.
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 4 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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Oscar Arrieta, MD ((+52) (55) 5628-0400 ext. 832, ogar@servidor.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory response (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT01048970, which also lists 4 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 14 Jan 2010.