A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

• ClinicalTrials.gov Identifier: NCT01419145
• Recruitment Status: Completed
• First Posted: August 17, 2011
• Last Update Posted: June 16, 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
• Information provided by (Responsible Party): Norwegian University of Science and Technology

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.

Condition or disease	Intervention/treatment	Phase
Cancer; Cachexia	Other: Multimodal intervention; Other: Standard care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
• Study Start Date: October 2011
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Multimodal intervention	Other: Multimodal intervention; 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.
Active Comparator: Standard Care	Other: Standard care; Standard cancer care

Outcome Measures

Primary Outcome Measures :

1. Feasibility of recruitment and retention [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Norway

Oslo University Hospital Ullevål

Oslo, Norway

St Olavs Hospital

Trondheim, Norway

United Kingdom

University of Edinburgh

Edinburgh, United Kingdom

Sponsors and Collaborators

Norwegian University of Science and Technology

University of Edinburgh

Oslo University Hospital

NHS Greater Glasgow and Clyde

Copenhagen University Hospital at Herlev

Investigators

• Principal Investigator: Stein Kaasa, MD, PhD; National Taiwan Normal University
• Principal Investigator: Ken Fearon, MD, PhD; University of Edinburgh

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Balstad TR, Brunelli C, Pettersen CH, Schønberg 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.

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). pii: E1925. doi: 10.3390/cancers11121925.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT01419145
• Other Study ID Numbers: 2010/2620 (REK); 2010-022897-14 ( EudraCT Number )
• First Posted: August 17, 2011
• Last Update Posted: June 16, 2017
• Last Verified: June 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:

cachexia; neoplasms; complications; combined modality therapy; exercise therapy; diet therapy; anti-inflammatory agents

Additional relevant MeSH terms:

Wasting Syndrome; Cachexia; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders