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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419145
• Other study ID #: 2010/2620 (REK)
• Secondary ID: 2010-022897-14
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: June 15, 2017
• Start date: October 2011
• Est. completion date: November 2014

Study information

• Verified date: June 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer

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.
• Standard care
Standard cancer care

Locations

Country	Name	City	State
Norway	Oslo University Hospital Ullevål	Oslo
Norway	St Olavs Hospital	Trondheim
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Copenhagen University Hospital at Herlev, NHS Greater Glasgow and Clyde, Oslo University Hospital, University of Edinburgh

Countries where clinical trial is conducted

Norway,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks

External Links

•   European Palliative Care Research Center