Back to resultsA Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Primary Purpose
Cancer, Cachexia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multimodal intervention
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring cachexia, neoplasms, complications, combined modality therapy, exercise therapy, diet therapy, anti-inflammatory agents
Eligibility Criteria
Main eligibility criteria:
- Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
- Due to commence chemo- or chemo radiotherapy
- Karnofsky Performance Score ≥ 70
- A life expectancy of ≥4 months and considered able to complete 2 months of the study
Sites / Locations
- Oslo University Hospital Ullevål
- St Olavs Hospital
- University of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multimodal intervention
Standard Care
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of recruitment and retention
The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions.
Secondary Outcome Measures
Full Information
NCT ID
NCT01419145
First Posted
August 16, 2011
Last Updated
June 15, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
University of Edinburgh, Oslo University Hospital, NHS Greater Glasgow and Clyde, Copenhagen University Hospital at Herlev
1. Study Identification
Unique Protocol Identification Number
NCT01419145
Brief Title
A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Official Title
A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
University of Edinburgh, Oslo University Hospital, NHS Greater Glasgow and Clyde, Copenhagen University Hospital at Herlev
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cachexia
Keywords
cachexia, neoplasms, complications, combined modality therapy, exercise therapy, diet therapy, anti-inflammatory agents
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimodal intervention
Arm Type
Experimental
Arm Title
Standard Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Multimodal intervention
Intervention Description
Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard cancer care
Primary Outcome Measure Information:
Title
Feasibility of recruitment and retention
Description
The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main eligibility criteria:
Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
Due to commence chemo- or chemo radiotherapy
Karnofsky Performance Score ≥ 70
A life expectancy of ≥4 months and considered able to complete 2 months of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, MD, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ken Fearon, MD, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital Ullevål
City
Oslo
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
University of Edinburgh
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28614627
Citation
Solheim TS, Laird BJA, Balstad TR, Stene GB, Bye A, Johns N, Pettersen CH, Fallon M, Fayers P, Fearon K, Kaasa S. A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):778-788. doi: 10.1002/jcsm.12201. Epub 2017 Jun 14.
Results Reference
result
PubMed Identifier
33585533
Citation
Balstad TR, Brunelli C, Pettersen CH, Schonberg SA, Skorpen F, Fallon M, Kaasa S, Bye A, Laird BJA, Stene GB, Solheim TS. Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial. Front Nutr. 2021 Jan 14;7:602775. doi: 10.3389/fnut.2020.602775. eCollection 2020.
Results Reference
derived
PubMed Identifier
31816924
Citation
Stene GB, Balstad TR, Leer ASM, Bye A, Kaasa S, Fallon M, Laird B, Maddocks M, Solheim TS. Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia. Cancers (Basel). 2019 Dec 3;11(12):1925. doi: 10.3390/cancers11121925.
Results Reference
derived
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A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
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