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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

288 Participants
are divided into 4 treatment groups
Group A: Placebo, no trainingPlacebo comparator 1 intervention
Group B: Placebo, training groupPlacebo comparator 2 interventions
Group C: Omega-3, no trainingExperimental treatment 1 intervention
Group D: Omega-3, training groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Skeletal Muscle Status I

Body composition: BIA (SMM in kg)

Time frame
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
2

Skeletal Muscle Status II

Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)

Time frame
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
3

Skeletal Muscle Status III

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

Time frame
Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
4

Skeletal Muscle Status IV

Handgrip strength: dynamometer (in kg)

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

Secondary outcomes

1

Patient-Reported Outcomes I

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

Time frame
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
2

Patient-Reported Outcomes II

Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

Time frame
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
3

Patient-Reported Outcomes III

Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale \[0-52, higher scores indicate better quality of life and less severe fatigue\]

Time frame
baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
4

Patient-Reported Outcomes III

Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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

Other outcomes

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