Cancer CachexiaNCT00815685
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
A study testing Eicosapentaenoic Acid in people with Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Eicosapentaenoic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women 25-80 years of age (inclusive)
- Confirmed diagnosis of Cancer (other than pancreatic cancer) Unintentional weight loss of >5% of body weight within 3 months of admission to the study
- Use of effective means of contraception (men and women) in patients of child-bearing potential
- Normal baseline liver function tests (LFTs) as determined by alanine aminotransferase (ALT) levels. Common Toxicity Criteria (CTC)) version 3 grade 1 elevation in ALT (>Upper Limit of Normal[UNL]-2.5 x UNL) withhold admitting participant to the study until recovery to normal; LFTs will be considered valid for consideration of eligibility if drawn within the previous 2 weeks, otherwise new labs will be drawn.
- Able and willing to give written informed consent : Each participant must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score >60%)
- Concurrent use of coumadin or warfarin is okay. The follow-up monitoring for prothrombin (PT), partial thromboplastin time (PTT) and International Normalized Ratio (INR) for patients on warfarin and/or coumadin will follow the standard of care as dictated by the prescribing physician. If the prescribing physician is not a Moffitt physician, then the prescribing physician will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT and INR will be obtained from patient during the 6 week study for review.
Who cannot join
- Patients with current diagnosis or history of pancreatic cancer
- Current use of anticoagulants other than coumadin, warfarin, or aspirin
- Use of other nutritional supplements other than multivitamins and minerals
- Allergy to fish or seafood
- Using Marinol or Megace
- Known history of hepatic or renal disease
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- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Evidence of bleeding diathesis or coagulopathy
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
- Pregnant (positive pregnancy test) or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Martin Memorial
Stuart, Florida, 34997
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.
Read the detailed description
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.
Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.
- Conditions
- Cancer Cachexia
- Being tested
- Eicosapentaenoic Acid
- Keywords
- n-3 fatty acids, nutritional treatment, molecular pathogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic AcidDrug
Also called Lovaza, EPA, omega-3-acid ethyl esters, docosahexaenoic acid
Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic Acid | Experimental | Not described Receives: Drug: Eicosapentaenoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Albumin
Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.
Measured: 6 weeks per patient
Secondary outcomes (1)
Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.
There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.
Measured: 6 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionMar 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Nagi Kumar, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815685
- Sponsor's protocol ID
- MCC-15190
- Status last verified
- Dec 2013
- First submitted
- 29 Dec 2008
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
- ClinicalTrials.gov ID
- NCT00815685
- Acronym / sponsor ID
- MCC-15190
- Conditions
- Cancer Cachexia
- Keywords
- n-3 fatty acids, nutritional treatment, molecular pathogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Posted 8 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.
Detailed description
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.
Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic Acid | Experimental | Drug: Eicosapentaenoic Acid |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and Women 25-80 years of age (inclusive)
- Confirmed diagnosis of Cancer (other than pancreatic cancer) Unintentional weight loss of >5% of body weight within 3 months of admission to the study
- Use of effective means of contraception (men and women) in patients of child-bearing potential
- Normal baseline liver function tests (LFTs) as determined by alanine aminotransferase (ALT) levels. Common Toxicity Criteria (CTC)) version 3 grade 1 elevation in ALT (>Upper Limit of Normal[UNL]-2.5 x UNL) withhold admitting participant to the study until recovery to normal; LFTs will be considered valid for consideration of eligibility if drawn within the previous 2 weeks, otherwise new labs will be drawn.
- Able and willing to give written informed consent : Each participant must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Key exclusion criteria (10 listed)
- Patients with current diagnosis or history of pancreatic cancer
- Current use of anticoagulants other than coumadin, warfarin, or aspirin
- Use of other nutritional supplements other than multivitamins and minerals
- Allergy to fish or seafood
- Using Marinol or Megace
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 |
|---|---|---|
| Eicosapentaenoic AcidAlso: Lovaza, EPA, omega-3-acid ethyl esters, docosahexaenoic acidParticipants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity. | Drug | Eicosapentaenoic Acid |
Primary outcome
Change in Serum Albumin
Time frame: 6 weeks per patient
Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.
1 secondary outcome
Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.
Time frame: 6 weeks per patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Visugromab in Cachexia International Trial
Cancer-associated Cachexia
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Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
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Oncologic Diseases
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.
Nagi Kumar, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eicosapentaenoic Acid in people with Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 23 Mar 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Albumin (time frame: 6 weeks per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2017.