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

NCT07643558 | Recruiting

• 1 other identifier: SUPPORT-Study
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Cachexia; Omega 3; Resistance Training; Cancer; Muscle Wasting; Systemic Inflammation

Keywords

Resistance training; Progressive resistance exercise; Exercise therapy; Supportive cancer care; Nutritional intervention; Protein-rich nutrition; Nutritional supplementation; Omega-3 fatty acids; Eicosapentaenoic acid (EPA); Docosahexaenoic acid (DHA); Fish oil supplementation; Physical performance; Quality of life; Fatigue; Appetite; Patient-reported outcomes; Randomized placebo-controlled trial; Cachexia risk

Outcome Measures

Primary Outcomes (10)

• Skeletal Muscle Status I

  Body composition: BIA (SMM in kg)

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

• Skeletal Muscle Status II

  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

  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

  Handgrip strength: dynamometer (in kg)

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

• Physical Performance I

  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

  Daily physical activity: International Physical Activity Questionnaire (IPAQ)

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

• Physical Performance III

  Accelerometry over 7 consecutive days (steps)

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

• Nutritional Status I

  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

  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

  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

Secondary Outcomes (6)

• Patient-Reported Outcomes I

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

• Patient-Reported Outcomes II

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

• Patient-Reported Outcomes III

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

• Patient-Reported Outcomes III

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

• Patient-Reported Outcomes IV

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

Study Arms (4)

Placebo, no training

PLACEBO COMPARATOR

Placebo (corn oli) and no training program

Dietary Supplement: Corn Oil Placebo, 4 capsules/day for 12 weeks

Placebo, training group

PLACEBO COMPARATOR

Placebo (corn oli) and 2x weekly resistance training

Behavioral: Training; Dietary Supplement: Corn Oil Placebo, 4 capsules/day for 12 weeks

Omega-3, no training

EXPERIMENTAL

Verum (Omega-3-capsules with fish oil) and no training program

Dietary Supplement: Omega 3 FA (Fish Oil)

Omega-3, training group

EXPERIMENTAL

Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training

Dietary Supplement: Omega 3 FA (Fish Oil); Behavioral: Training

Interventions

Omega 3 FA (Fish Oil) DIETARY_SUPPLEMENT

4x capsules containing 500 mg EPA and 250 mg DHA

Omega-3, no training; Omega-3, training group

Training BEHAVIORAL

2x weekly resistance training

Omega-3, training group; Placebo, training group

Corn Oil Placebo, 4 capsules/day for 12 weeks DIETARY_SUPPLEMENT

4x capsueles daily

Placebo, no training; Placebo, training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Hector-Center for Nutrition, Exercise and Sports

Erlangen, Bavaria, 91056, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms; Muscular Atrophy; Fatigue

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Yurdagül Zopf, Prof. Dr. med.

  Universitätsklinikum Erlangen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: June 11, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)