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

Official 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

Overview

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.

Interventions

• Dietary supplement Omega 3 FA (Fish Oil)
  4x capsules containing 500 mg EPA and 250 mg DHA
• Behavioral Training
  2x weekly resistance training
• Dietary supplement Corn Oil Placebo, 4 capsules/day for 12 weeks
  4x capsueles daily

Primary outcome measures

• Skeletal Muscle Status I [Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status II [Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status III [Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Skeletal Muscle Status IV [Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance I [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance II [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Physical Performance III [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status I [Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status II [Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]
• Nutritional Status III [Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion]

Secondary outcome measures (6)

• Patient-Reported Outcomes I [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes II [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes III [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes III [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Patient-Reported Outcomes IV [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]
• Omega-3-Index [Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Germany · 1 center

• Hector-Center for Nutrition, Exercise and Sports — Erlangen

Identifiers

NCT: NCT07643558 · SUPPORT-Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗