Back to results

A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

Primary Purpose

Cancer Cachexia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Eicosapentaenoic Acid

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring n-3 fatty acids, nutritional treatment, molecular pathogenesis

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Sites / Locations

Martin Memorial
H. Lee Moffitt Cancer Center & Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eicosapentaenoic Acid

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00815685

First Posted

December 29, 2008

Last Updated

February 20, 2017

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00815685

Brief Title

A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

Official Title

A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Cachexia

Keywords

n-3 fatty acids, nutritional treatment, molecular pathogenesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eicosapentaenoic Acid

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Eicosapentaenoic Acid

Other Intervention Name(s)

Lovaza, EPA, omega-3-acid ethyl esters, docosahexaenoic acid, DHA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Serum Albumin

Description

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.

Time Frame

6 weeks per patient

Secondary Outcome Measure Information:

Title

Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.

Description

Time Frame

6 weeks per patient

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nagi Kumar, Ph.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Martin Memorial

City

Stuart

State/Province

Florida

ZIP/Postal Code

34997

Country

United States

Facility Name

H. Lee Moffitt Cancer Center & Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

We'll reach out to this number within 24 hrs