CachexiaPhase 3MENACNCT02330926
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
A Phase 3 study testing nutritional supplements and advice, home-based self-assisted exercise program and Ibuprofen in people with Cachexia and Neoplasms, run by Norwegian University of Science and Technology at 17 sites in 6 countries.
Trial summary
Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- nutritional supplements and advice, home-based self-assisted exercise program and Ibuprofen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Apr 2015to Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation
- non-small cell lung cancer (stage III or IV), pancreatic adenocarcinoma (stage III or IV), due to commence first or second line anticancer treatment (defined as chemotherapy, chemo-radiotherapy, targeted therapy or immunotherapy)
- staging CT within 4 weeks of commencement of anti-cancer therapy (in patients where staging CT is out-with this period, further CT scanning will be undertaken. PETCT's are also appropriate)
- completed all other baseline assessments within one week prior to first course of anti-cancer treatment
- written informed consent
- able to comply with trial interventions (in the opinion of referring clinician) e.g. willing and able to do light exercise and take oral nutritional supplements as well as no major contraindications against ibuprofen.
- Karnofsky Performance Status >70
Who cannot join
- Neuro-endocrine pancreatic cancer
- Creatinine clearance <30ml/min
- Receiving parenteral nutrition or enteral nutrition via feeding tube
- receiving neo-adjuvant anti-cancer therapy
- BMI >30 kg/m2
- Use of appetite stimulants or anabolic/anti-catabolic agents (such as megestrol acetate, progestational agents, marijuana growth hormone, dronabinol, or other anabolic agent) within 30 days prior to study baseline
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- Concomitant steroid (>10mg/d prednisolone or equivalent) treatment for less than three months prior to inclusion (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted)
- Concomitant long term (>1 week) nonsteroidal anti-inflammatory drugs (NSAID) or aspirin treatment
- pregnancy, breast-feeding or of child bearing potential (that is not postmenopausal or permanently sterilised) age and not using adequate contraception (oral, injected, implanted or hormonal methods of contraception, intrauterine device and barrier method)
- Concomitant anti-coagulant treatment (e.g. warfarin or heparin)
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United Kingdom7 sites
Llandough Hospital
Cardiff
Queen Margaret Hospital
Dunfermline, Fife
Edinburgh Cancer Centre
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
NHS Forth Valley
Larbert, Falkirk
Chelsea and Westminister Hospital NHS
London
Guys and St Thomas
London
Canada4 sites
CA4 Brampton Civic Hospital
Brampton
Cross Cancer Insitute
Edmonton
Jewish General Hospital
Montreal
Ottawa Regional Cancer Centre
Ottawa
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, CA 90048
About this study
Official title: A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment.
There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem.
The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.
- Being tested
- standard care, nutritional supplements and advice, home-based self-assisted exercise program, Ibuprofen
- Keywords
- Combined modality treatment, Diet therapy, Exercise therapy, Ibuprofen, Dietary supplements
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
Routine oncology and palliative care
nutritional supplements and adviceDietary supplement
n-3 PUFA enriched supplements, dietary advice
home-based self-assisted exercise programBehavioural
Strength and aerobic
IbuprofenDrug
400mgx3
| Study group | Role | What they receive |
|---|---|---|
| multimodal intervention | Experimental | standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen) Receives: Other: standard care; Dietary Supplement: nutritional supplements and advice; Behavioral: home-based self-assisted exercise program; Drug: Ibuprofen |
| standard care | Active comparator | standard palliative care Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight
body weight (Kg)
Measured: 6 weeks
Secondary outcomes (2)
change in muscle mass
CT L3 cross sectional area
Measured: 6 weeks
change in physical activity
ActivPAL step count
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2023
- Study completionApr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Oslo University Hospital, Cantonal Hospital of St. Gallen, Ottawa Regional Cancer Centre, Jewish General Hospital, Cross Cancer Institute, Beatson West of Scotland Cancer Centre, Queen Margaret Hospital, Dunfermline, Cancer Research UK Edinburgh Centre, Malteser Krankenhaus Seliger Gerhardt, Tumor Biology Center Freiburg, Tumor Zentrum Aarau, Chelsea and Westminster NHS Foundation Trust, Cedars-Sinai Medical Center, Guy's and St Thomas' NHS Foundation Trust, NHS Forth Valley
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD PhD, Study director, European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, NorwayMarie Fallon, MD PhD, Study director, Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330926
- Sponsor's protocol ID
- MENAC-2013-05
- Other IDs
- 2013-002282-19
- Acronym
- MENAC
- Status last verified
- Aug 2025
- First submitted
- 31 Dec 2014
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Solheim TS, Laird BJA, Balstad TR, Bye A, Stene G, Baracos V, Strasser F, Griffiths G, Maddocks M, Fallon M, Kaasa S, Fearon K. Cancer cachexia: rationale for the MENAC (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial. BMJ Support Palliat Care. 2018 Sep;8(3):258-265. doi: 10.1136/bmjspcare-2017-001440. Epub 2018 Feb 9.
PubMed 29440149Naito T. Challenges in enhancing physical performance in thoracic cancer cachexia. Thorac Cancer. 2021 Oct;12(20):2633-2634. doi: 10.1111/1759-7714.14154. Epub 2021 Sep 15. No abstract available.
PubMed 34528401
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT02330926
- Acronym / sponsor ID
- MENAC / MENAC-2013-05
- Keywords
- Combined modality treatment, Diet therapy, Exercise therapy, Ibuprofen, Dietary supplements
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Oslo University Hospital, Cantonal Hospital of St. Gallen, Ottawa Regional Cancer Centre, Jewish General Hospital, Cross Cancer Institute, Beatson West of Scotland Cancer Centre, Queen Margaret Hospital, Dunfermline, Cancer Research UK Edinburgh Centre, Malteser Krankenhaus Seliger Gerhardt, Tumor Biology Center Freiburg, Tumor Zentrum Aarau, Chelsea and Westminster NHS Foundation Trust, Cedars-Sinai Medical Center, Guy's and St Thomas' NHS Foundation Trust, NHS Forth Valley
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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 multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment.
There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem.
The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multimodal intervention | Experimental | Other: standard care, Dietary Supplement: nutritional supplements and advice, Behavioral: home-based self-assisted exercise program, Drug: Ibuprofenstandard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen) |
| standard care | Active comparator | Other: standard carestandard palliative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation
- non-small cell lung cancer (stage III or IV), pancreatic adenocarcinoma (stage III or IV), due to commence first or second line anticancer treatment (defined as chemotherapy, chemo-radiotherapy, targeted therapy or immunotherapy)
- staging CT within 4 weeks of commencement of anti-cancer therapy (in patients where staging CT is out-with this period, further CT scanning will be undertaken. PETCT's are also appropriate)
- completed all other baseline assessments within one week prior to first course of anti-cancer treatment
- written informed consent
Key exclusion criteria (10 listed)
- Neuro-endocrine pancreatic cancer
- Creatinine clearance <30ml/min
- Receiving parenteral nutrition or enteral nutrition via feeding tube
- receiving neo-adjuvant anti-cancer therapy
- BMI >30 kg/m2
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 |
|---|---|---|
| standard careRoutine oncology and palliative care | Other | multimodal intervention, standard care |
| nutritional supplements and advicen-3 PUFA enriched supplements, dietary advice | Dietary supplement | multimodal intervention |
| home-based self-assisted exercise programStrength and aerobic | Behavioural | multimodal intervention |
| Ibuprofen400mgx3 | Drug | multimodal intervention |
Primary outcome
change in body weight
Time frame: 6 weeks
body weight (Kg)
2 secondary outcomes
change in muscle mass
Time frame: 6 weeks
change in physical activity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 29440149Solheim TS, Laird BJA, Balstad TR, Bye A, Stene G, Baracos V, Strasser F, Griffiths G, Maddocks M, Fallon M, Kaasa S, Fearon K. Cancer cachexia: rationale for the MENAC (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial. BMJ Support Palliat Care. 2018 Sep;8(3):258-265. doi: 10.1136/bmjspcare-2017-001440. Epub 2018 Feb 9.
- Derived from this study: PubMed 34528401Naito T. Challenges in enhancing physical performance in thoracic cancer cachexia. Thorac Cancer. 2021 Oct;12(20):2633-2634. doi: 10.1111/1759-7714.14154. Epub 2021 Sep 15. No abstract available.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Stein Kaasa, MD PhD study director
European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
Marie Fallon, MD PhD study director
Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nutritional supplements and advice, home-based self-assisted exercise program and Ibuprofen in people with Cachexia and Neoplasms, run by Norwegian University of Science and Technology at 17 sites in 6 countries.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Canada, Norway, Switzerland, United States and 1 more country. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body weight (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330926, which also lists 2 linked publications.
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 29 Aug 2025.