A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
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ClinicalTrials.gov Identifier: NCT01419145 |
Recruitment Status :
Completed
First Posted : August 17, 2011
Last Update Posted : June 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Cachexia | Other: Multimodal intervention Other: Standard care | Not Applicable |
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 |

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 |
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419145
Norway | |
Oslo University Hospital Ullevål | |
Oslo, Norway | |
St Olavs Hospital | |
Trondheim, Norway | |
United Kingdom | |
University of Edinburgh | |
Edinburgh, United Kingdom |
Principal Investigator: | Stein Kaasa, MD, PhD | National Taiwan Normal University | |
Principal Investigator: | Ken Fearon, MD, PhD | University of Edinburgh |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |
cachexia neoplasms complications combined modality therapy |
exercise therapy diet therapy anti-inflammatory agents |
Wasting Syndrome Cachexia Emaciation Weight Loss |
Body Weight Changes Body Weight Metabolic Diseases Nutrition Disorders |