Cancer CachexiaSUPPORTNCT07643558
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
A study testing Omega 3 FA (Fish Oil) and Training in people with Cancer Cachexia and Omega 3, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia, Omega 3, Resistance Training
- What is being tested?
- Omega 3 FA (Fish Oil) and Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Bavaria, 91056
Prof. Dr. med. Yurdagül Zopf, 0049091318545220, yurdaguel.zopf@uk-erlangen.de
About this study
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
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
- Being tested
- Omega 3 FA (Fish Oil), Training, Corn Oil Placebo, 4 capsules/day for 12 weeks
- 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
- Medical subject headings
- Neoplasms, Muscular Atrophy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 FA (Fish Oil)Dietary supplement
4x capsules containing 500 mg EPA and 250 mg DHA
TrainingBehavioural
2x weekly resistance training
Corn Oil Placebo, 4 capsules/day for 12 weeksDietary supplement
4x capsueles daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo, no training | Placebo comparator | Placebo (corn oli) and no training program Receives: Dietary Supplement: Corn Oil Placebo, 4 capsules/day for 12 weeks |
| Placebo, training group | Placebo comparator | Placebo (corn oli) and 2x weekly resistance training Receives: 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 Receives: Dietary Supplement: Omega 3 FA (Fish Oil) |
| Omega-3, training group | Experimental | Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training Receives: Dietary Supplement: Omega 3 FA (Fish Oil); Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Status I
Body composition: BIA (SMM in kg)
Measured: 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)
Measured: 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)
Measured: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Skeletal Muscle Status IV
Handgrip strength: dynamometer (in kg)
Measured: 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)
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Physical Performance II
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Physical Performance III
Accelerometry over 7 consecutive days (steps)
Measured: 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)]
Measured: 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)
Measured: 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)
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Secondary outcomes (6)
Patient-Reported Outcomes I
Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes II
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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]
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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)
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Patient-Reported Outcomes IV
Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Omega-3-Index
Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
Measured: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jan 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yurdagül Zopf, Prof. Dr. med., Study chair, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643558
- Sponsor's protocol ID
- SUPPORT-Study
- Acronym
- SUPPORT
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07643558
- Acronym / sponsor ID
- SUPPORT / SUPPORT-Study
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo, no training | Placebo comparator | Dietary Supplement: Corn Oil Placebo, 4 capsules/day for 12 weeksPlacebo (corn oli) and no training program |
| Placebo, training group | Placebo comparator | Behavioral: Training, Dietary Supplement: Corn Oil Placebo, 4 capsules/day for 12 weeksPlacebo (corn oli) and 2x weekly resistance training |
| Omega-3, no training | Experimental | Dietary Supplement: Omega 3 FA (Fish Oil)Verum (Omega-3-capsules with fish oil) and no training program |
| Omega-3, training group | Experimental | Dietary Supplement: Omega 3 FA (Fish Oil), Behavioral: TrainingVerum (Omega-3-capsules with fish oil) and 2x weekly resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 FA (Fish Oil)4x capsules containing 500 mg EPA and 250 mg DHA | Dietary supplement | Omega-3, no training, Omega-3, training group |
| Training2x weekly resistance training | Behavioural | Omega-3, training group, Placebo, training group |
| Corn Oil Placebo, 4 capsules/day for 12 weeks4x capsueles daily | Dietary supplement | Placebo, no training, Placebo, training group |
Primary outcome
Skeletal Muscle Status I
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Body composition: BIA (SMM in kg)
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)
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)
Skeletal Muscle Status IV
Time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Handgrip strength: dynamometer (in kg)
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)
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)
Physical Performance III
Time frame: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Accelerometry over 7 consecutive days (steps)
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)]
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)
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Germany
Yurdagül Zopf, Prof. Dr. med. study chair
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 FA (Fish Oil) and Training in people with Cancer Cachexia and Omega 3, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Status I (time frame: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.