Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gary Morrow
With
National Cancer Institute (NCI)
PRIMARY OBJECTIVE:
I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks.
ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
ARM III: Patients receive placebo PO BID for 6 weeks.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
Be able to read English
Able to swallow medication
Give written informed consent
You may not be if
Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
Be taking anticoagulant medication (does not include aspirin)
Have sensitivity or allergy to fish and/or shellfish
Have sensitivity or allergy to soy and/or soybeans
Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
