fish oil trial

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http://www.clinicaltrials.gov/ct/show/NCT00094562?order=3

A Fish Oil Supplement to Maintain Body Weight in Patients with Cancer

This study is currently recruiting patients.

Verified by National Center for Complementary and Alternative Medicine

(NCCAM) September 2005

Sponsored by: National Center for Complementary and Alternative

Medicine (NCCAM)

Information provided by: National Center for Complementary and

Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier: NCT00094562

Purpose

The purpose of this study is to evaluate the safety and effectiveness

of fish oil supplements in maintaining weight in people with cancer.

Condition Intervention Phase

Cancer

Cancer Cachexia

Drug: Fish oil supplement

Phase III

MedlinePlus related topics: Cancer; Cancer Alternative Therapies

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control,

Parallel Assignment, Safety/Efficacy Study

Official Title: AAFA Fish Oil Nutritional Supplement to Maintain Body

Weight in Patients with Cancer

Further Study Details:

Primary Outcomes: Body weight; lean body mass

Expected Total Enrollment: 60

Study start: June 2004; Expected completion: September 2007

Last follow-up: September 2007

Cancer patients have a high occurrence of weight loss and decreased

functional status and quality of life. Standard cancer treatments,

such as chemotherapy and radiation, do not help to sustain weight in

these patients; therefore, the evaluation of nutritional supplements

for weight maintenance in cancer patients is warranted.

Participants will be randomly assigned to receive either fish oil

supplements or placebo for the duration of this 3-month study.

Participants will have five study visits and two telephone interviews.

During each study visit, participants will undergo laboratory tests, a

physical exam, and a dual energy X-ray absorptiometry (DEXA) bone

scan. Participants will be asked to keep a food diary during the

study. During the telephone interviews, participants will be asked

health-related questions and discuss their current functional status.

Eligibility

Ages Eligible for Study: 18 Years - 90 Years, Genders Eligible

for Study: Both

Criteria

Inclusion Criteria:

* Any Pancreatic cancer or any other cancer with a 5% weight loss

* Surgery for cancer at least 6 weeks prior to study entry

* On a stable dose of medications for at least 6 weeks prior to

study entry

* Meet certain laboratory test requirements

* Postmenopausal or premenopausal but highly unlikely to conceive,

for female participants

* Agree to use acceptable methods of contraception during the

study and for 3 months after study completion, for female participants

* Willing to continue current therapy for cancer for the duration

of the study

Exclusion Criteria:

* Esophageal Cancer

* Life expectancy of less than 12 weeks

* Alcohol consumption more than 3 drinks/day for men or 2

drinks/day for women

* Untreated endocrine problems

* Gonadal dysfunction from a known primary endocrine dysfunction

* Medications that impair sex hormone synthesis, secretion, or

function

* Megestrol acetate within 6 weeks prior to study entry

* Fish oils within 3 months prior to study entry

* Any infectious disease, such as HIV or viral hepatitis

* Vitamins in doses greater than the Recommended Daily Allowance (RDA)

* Herbs in the month prior to study entry

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00094562

Ann V. Munson, MS, RD amunson1@...

land

s Hopkins Hospital, Baltimore, land, 21287, United

States; Recruiting

Ann V. Munson, MS, RD amunson1@...

S. Dobs, MD, MHS, Principal Investigator

Study chairs or principal investigators

S. Dobs, MD, MHS, Principal Investigator, s Hopkins

University

More Information

Study ID Numbers: JHM - IRB # 03-02-10-12

Last Updated: September 29, 2005

Record first received: October 20, 2004

ClinicalTrials.gov Identifier: NCT00094562

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on 2005-10-06