- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02352779
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- Wichita NCORP
-
-
Michigan
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Grand Rapids, Michigan, Forente stater, 49503
- Cancer Research Consortium of West Michigan
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-
New York
-
Rochester, New York, Forente stater, 14642
- University of Rochester NCORP Research Base
-
-
Ohio
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Dayton, Ohio, Forente stater, 45420
- Dayton NCORP
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Greenville Health System NCORP
-
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Wisconsin
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Marshfield, Wisconsin, Forente stater, 54449
- Wisconsin NCORP
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
|
Korrelative studier
Gitt PO
Andre navn:
Hjelpestudier
Given PO
Andre navn:
|
Eksperimentell: Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
|
Korrelative studier
Hjelpestudier
Given PO
Andre navn:
|
Placebo komparator: Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
|
Korrelative studier
Gitt PO
Andre navn:
Hjelpestudier
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
Tidsramme: Baseline to 6 weeks
|
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine). MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue). |
Baseline to 6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.
- Inglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- URCC13091 (Annen identifikator: University of Rochester NCORP Research Base)
- UG1CA189961 (U.S. NIH-stipend/kontrakt)
- NCI-2014-01191 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- URCC-13091 (Annen identifikator: CTEP)
- U10CA037420 (U.S. NIH-stipend/kontrakt)
- R03CA175599 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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