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

Primary Purpose

Cachexia, Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
standard care
nutritional supplements and advice
home-based self-assisted exercise program
Ibuprofen
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cachexia focused on measuring Combined modality treatment, Diet therapy, Exercise therapy, Ibuprofen, Dietary supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cedars-Sinai Medical Center
  • CA4 Brampton Civic Hospital
  • Cross Cancer Insitute
  • Jewish General Hospital
  • Ottawa Regional Cancer Centre
  • Universitätsklinikum Bonn
  • Oslo University Hospital
  • St Olavs Hospital
  • Tumor Zentrum
  • Cantonal Hospital
  • NHS Forth Valley
  • Queen Margaret Hospital
  • Llandough Hospital
  • Edinburgh Cancer Centre
  • Beatson West of Scotland Cancer Centre
  • Chelsea and Westminister Hospital NHS
  • Guys and St Thomas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multimodal intervention

standard care

Arm Description

standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)

standard palliative care

Outcomes

Primary Outcome Measures

change in body weight

Secondary Outcome Measures

change in muscle mass
change in physical activity

Full Information

First Posted
December 31, 2014
Last Updated
May 3, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Oslo University Hospital, Cantonal Hospital of St. Gallen, Ottawa Regional Cancer Centre, Jewish General Hospital, Cross Cancer Institute, 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, Chelsea and Westminster NHS Foundation Trust, Cedars-Sinai Medical Center, Guy's and St Thomas' NHS Foundation Trust, NHS Forth Valley
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1. Study Identification

Unique Protocol Identification Number
NCT02330926
Brief Title
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2023 (Actual)
Study Completion Date
April 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Oslo University Hospital, Cantonal Hospital of St. Gallen, Ottawa Regional Cancer Centre, Jewish General Hospital, Cross Cancer Institute, 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, Chelsea and Westminster NHS Foundation Trust, Cedars-Sinai Medical Center, Guy's and St Thomas' NHS Foundation Trust, NHS Forth Valley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Neoplasms
Keywords
Combined modality treatment, Diet therapy, Exercise therapy, Ibuprofen, Dietary supplements

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multimodal intervention
Arm Type
Experimental
Arm Description
standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
standard palliative care
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Type
Other
Intervention Name(s)
nutritional supplements and advice
Intervention Type
Other
Intervention Name(s)
home-based self-assisted exercise program
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Primary Outcome Measure Information:
Title
change in body weight
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
change in muscle mass
Time Frame
6 weeks
Title
change in physical activity
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, MD PhD
Organizational Affiliation
European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marie Fallon, MD PhD
Organizational Affiliation
Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
CA 90048
Country
United States
Facility Name
CA4 Brampton Civic Hospital
City
Brampton
Country
Canada
Facility Name
Cross Cancer Insitute
City
Edmonton
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
Country
Canada
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Tumor Zentrum
City
Aarau
Country
Switzerland
Facility Name
Cantonal Hospital
City
St. Gallen
Country
Switzerland
Facility Name
NHS Forth Valley
City
Larbert
State/Province
Falkirk
Country
United Kingdom
Facility Name
Queen Margaret Hospital
City
Dunfermline
State/Province
Fife
Country
United Kingdom
Facility Name
Llandough Hospital
City
Cardiff
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre
City
Edinburgh
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
Chelsea and Westminister Hospital NHS
City
London
Country
United Kingdom
Facility Name
Guys and St Thomas
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29440149
Citation
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.
Results Reference
background
PubMed Identifier
34528401
Citation
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.
Results Reference
derived

Learn more about this trial

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

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