Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy (MENAC)

August 22, 2025 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Brampton, Canada
        • CA4 Brampton Civic Hospital
      • Edmonton, Canada
        • Cross Cancer Insitute
      • Montreal, Canada
        • Jewish General Hospital
      • Ottawa, Canada
        • Ottawa Regional Cancer Centre
  • Germany
      • Bonn, Germany
        • Universitätsklinikum Bonn
  • Norway
      • Oslo, Norway
        • Oslo University Hospital
      • Trondheim, Norway
        • St Olavs hospital
  • Switzerland
      • Aarau, Switzerland
        • Tumor Zentrum
      • Sankt Gallen, Switzerland
        • Cantonal Hospital
  • United Kingdom
      • Cardiff, United Kingdom
        • LLandough Hospital
      • Edinburgh, United Kingdom
        • Edinburgh Cancer Centre
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom
        • Chelsea and Westminister Hospital NHS
      • London, United Kingdom
        • Guys and St Thomas
    • Falkirk
      • Larbert, Falkirk, United Kingdom
        • NHS Forth Valley
    • Fife
      • Dunfermline, Fife, United Kingdom
        • Queen Margaret Hospital
  • United States
    • California
      • Los Angeles, California, United States, CA 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multimodal intervention
standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)
Other: standard care
Routine oncology and palliative care
Dietary supplement: nutritional supplements and advice
n-3 PUFA enriched supplements, dietary advice
Behavioral: home-based self-assisted exercise program
Strength and aerobic
Drug: Ibuprofen
400mgx3
Active Comparator: standard care
standard palliative care
Other: standard care
Routine oncology and palliative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight
Time Frame: 6 weeks
body weight (Kg)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in muscle mass
Time Frame: 6 weeks
CT L3 cross sectional area
6 weeks
change in physical activity
Time Frame: 6 weeks
ActivPAL step count
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Oslo University Hospital
Guy's and St Thomas' NHS Foundation Trust
Cedars-Sinai Medical Center
St. Olavs Hospital
Chelsea and Westminster NHS Foundation Trust
Jewish General Hospital
Cross Cancer Institute
Cantonal Hospital of St. Gallen
Ottawa Regional Cancer Centre
The 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
NHS Forth Valley

Investigators

  • Study Director: Stein Kaasa, MD PhD, European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
  • Study Director: Marie Fallon, MD PhD, Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimated)

January 5, 2015

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MENAC-2013-05
  • 2013-002282-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on standard care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe