Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

Neoplasms Clinical Trial

— MENAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330926
• Other study ID #: MENAC-2013-05
• Secondary ID: 2013-002282-19
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: April 2023

Study information

• Verified date: June 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cachexia
• Neoplasms

Intervention

Other:
• standard care

• nutritional supplements and advice

• home-based self-assisted exercise program

Drug:
• Ibuprofen

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

Norwegian University of Science and Technology

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

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Norway,  Switzerland,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight		6 weeks
Secondary	change in muscle mass		6 weeks
Secondary	change in physical activity		6 weeks