Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

NCT02330926 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: MENAC-2013-052013-002282-19
• Study Type: interventional
• Target: 221
• Locations: 6 countries
• Sites: 17

Brief 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. 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.

Conditions

Cachexia; Neoplasms

Keywords

Combined modality treatment; Diet therapy; Exercise therapy; Ibuprofen; Dietary supplements

Outcome Measures

Primary Outcomes (1)

• change in body weight

  body weight (Kg)

  6 weeks

Secondary Outcomes (2)

• change in muscle mass

  6 weeks

• change in physical activity

  6 weeks

Study Arms (2)

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)

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

Other: standard care

Interventions

standard care OTHER

Routine oncology and palliative care

multimodal intervention; standard care

nutritional supplements and advice DIETARY_SUPPLEMENT

n-3 PUFA enriched supplements, dietary advice

multimodal intervention

home-based self-assisted exercise program BEHAVIORAL

Strength and aerobic

multimodal intervention

Ibuprofen DRUG

400mgx3

multimodal intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Ottawa Regional Cancer Centre: collaborator
• Jewish General Hospital: collaborator
• Cross Cancer Institute: collaborator
• The Beatson West of Scotland Cancer Centre: collaborator
• Queen Margaret Hospital, Dunfermline: collaborator
• Cancer Research UK Edinburgh Centre: collaborator
• Malteser Krankenhaus Seliger Gerhardt: collaborator
• Tumor Biology Center Freiburg: collaborator
• Tumor Zentrum Aarau: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• Cedars-Sinai Medical Center: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• NHS Forth Valley: collaborator

Study Sites (17)

Cedars-Sinai Medical Center

Los Angeles, California, CA 90048, United States

Location

CA4 Brampton Civic Hospital

Brampton, Canada

Location

Cross Cancer Insitute

Edmonton, Canada

Location

Jewish General Hospital

Montreal, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Canada

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Oslo University Hospital

Oslo, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Tumor Zentrum

Aarau, Switzerland

Location

Cantonal Hospital

Sankt Gallen, Switzerland

Location

NHS Forth Valley

Larbert, Falkirk, United Kingdom

Location

Queen Margaret Hospital

Dunfermline, Fife, United Kingdom

Location

Llandough Hospital

Cardiff, United Kingdom

Location

Edinburgh Cancer Centre

Edinburgh, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Chelsea and Westminister Hospital NHS

London, United Kingdom

Location

Guys and St Thomas

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29440149 BACKGROUND

• Naito 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.

  PMID: 34528401 DERIVED

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Standard of Care; Dietary Supplements; Counseling; Ibuprofen

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 5, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CH (2); GB (7); US (1); NO (2); CA (4); DE (1)