Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients (SUPPORT)
8. juni 2026 oppdatert av: University of Erlangen-Nürnberg Medical School
SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids/ Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients
Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.
In addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.
The aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
288
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Bavaria
-
Erlangen, Bavaria, Tyskland, 91056
- Rekruttering
- Hector-Center for Nutrition, Exercise and Sports
-
Ta kontakt med:
- Prof. Dr. med. Yurdagül Zopf
- Telefonnummer: 0049091318545220
- E-post: yurdaguel.zopf@uk-erlangen.de
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages
- Women and men aged 18 years or older
- ECOG performance status 0-2
Exclusion Criteria:
- Patients younger than 18 years
- Bone metastases or skeletal involvement associated with a high risk of fracture
- Pregnant or breastfeeding women
- Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent
- Participation in other exercise and/or nutritional intervention studies within the previous 3 months
- Current use of fish oil supplements
- Severe cardiovascular disease, NYHA class IV
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo, no training
Placebo (corn oli) and no training program
|
4x capsueles daily
|
|
Placebo komparator: Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
|
4x capsueles daily
2x weekly resistance training
|
|
Eksperimentell: Omega-3, no training
Verum (Omega-3-capsules with fish oil) and no training program
|
4x capsules containing 500 mg EPA and 250 mg DHA
|
|
Eksperimentell: Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
|
2x weekly resistance training
4x capsules containing 500 mg EPA and 250 mg DHA
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skeletal Muscle Status I
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Body composition: BIA (SMM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status II
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status III
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Skeletal Muscle Status IV
Tidsramme: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Handgrip strength: dynamometer (in kg)
|
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance I
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Functional exercise capacity: 6-minute walk test (distance in m)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance II
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance III
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Accelerometry over 7 consecutive days (steps)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status I
Tidsramme: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) [0 (no risk) - 7 (highest risk)]
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status II
Tidsramme: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Nutritional Status III
Tidsramme: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Dietary intake and nutrient analysis: 3 or 7-day dietary record and assessment of consumption of EPA- and DHA-rich foods, and omega-3/omega-6 fatty acid ratio (in g)
|
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-Reported Outcomes I
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes II
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale [0-52, higher scores indicate better quality of life and less severe fatigue]
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes III
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Patient-Reported Outcomes IV
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Omega-3-Index
Tidsramme: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
|
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Yurdagül Zopf, Prof. Dr. med., Universitätsklinikum Erlangen
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2026
Primær fullføring (Antatt)
1. oktober 2028
Studiet fullført (Antatt)
1. oktober 2029
Datoer for studieregistrering
Først innsendt
14. januar 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. januar 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Livskvalitet
- Utmattelse
- Eikosapentaensyre (EPA)
- Dokosaheksaensyre (DHA)
- Omega-3 fettsyrer
- Treningsterapi
- Appetitt
- Motstandstrening
- Kosttilskudd
- Pasientrapporterte utfall
- Fysisk ytelse
- Støttende kreftomsorg
- Ernæringsmessig intervensjon
- Fiskeoljetilskudd
- Randomisert placebokontrollert studie
- Progressiv motstandsøvelse
- Protein-rich nutrition
- Cachexia risk
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SUPPORT-Study
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .