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NCT Number: NCT07643558

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hector-Center for Nutrition, Exercise and Sports

Erlangen, Bavaria, 91056, Germany

Location status: Recruiting

Location contact

Prof. Dr. med. Yurdagül Zopf

CONTACT

[email protected]

0049091318545220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3 FA (Fish Oil)

Dietary Supplement

4x capsules containing 500 mg EPA and 250 mg DHA

Training

Behavioral

2x weekly resistance training

Corn Oil Placebo, 4 capsules/day for 12 weeks

Dietary Supplement

4x capsueles daily

Primary outcomes

  1. Skeletal Muscle Status I

    Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Body composition: BIA (SMM in kg)

  2. Skeletal Muscle Status II

    Time frame: 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)

  3. Skeletal Muscle Status III

    Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)

  4. Skeletal Muscle Status IV

    Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Handgrip strength: dynamometer (in kg)

  5. Physical Performance I

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Functional exercise capacity: 6-minute walk test (distance in m)

  6. Physical Performance II

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Daily physical activity: International Physical Activity Questionnaire (IPAQ)

  7. Physical Performance III

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Accelerometry over 7 consecutive days (steps)

  8. Nutritional Status I

    Time frame: 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)]

  9. Nutritional Status II

    Time frame: 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)

  10. Nutritional Status III

    Time frame: 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)

Secondary outcomes

  1. Patient-Reported Outcomes I

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])

  2. Patient-Reported Outcomes II

    Time frame: 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)

  3. Patient-Reported Outcomes III

    Time frame: 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]

  4. Patient-Reported Outcomes III

    Time frame: 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)

  5. Patient-Reported Outcomes IV

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]

  6. Omega-3-Index

    Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion

    Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: SUPPORT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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