A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
This study is currently recruiting participants.
Verified May 2013 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
Collaborators:
University of Edinburgh
Oslo University Hospital
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01419145
First received: August 16, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer Cachexia |
Other: Multimodal intervention Other: Standard care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study |
Resource links provided by NLM:
Further study details as provided by Norwegian University of Science and Technology:
Primary Outcome Measures:
- Feasibility of recruitment and retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419145
Contacts
| Contact: Stein Kaasa, MD, PhD | stein.kaasa@ntnu.no | |
| Contact: Ken Fearon, MD, PhD | k.fearon@ed.ac.uk |
Locations
| Denmark | |
| Rigshospitalet, Onkologisk Klinikk | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Seppo W Langer, md | |
| Herlev Hospital, Onkologisk Afdeling R | Recruiting |
| Herlev, Denmark, 2730 | |
| Contact: Anders Mellemgaard | |
| Norway | |
| Oslo University Hospital Ullevål | Recruiting |
| Oslo, Norway | |
| Contact: Asta Bye ASTBYE@ous-hf.no | |
| St Olavs Hospital | Recruiting |
| Trondheim, Norway | |
| Contact: Stein Kaasa, PhD MD stein.kaasa@ntnu.no | |
| Contact: Trude R Balstad, MSc trude.r.balstad@ntnu.no | |
| Sub-Investigator: Trude R Balstad, MSc | |
| United Kingdom | |
| University of Edinburgh | Recruiting |
| Edinburgh, United Kingdom | |
| Contact: Ken Fearon, PhD MD k.fearon@ed.ac.uk | |
| Contact: Barry Laird | |
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Edinburgh
Oslo University Hospital
NHS Greater Glasgow and Clyde
Investigators
| Principal Investigator: | Stein Kaasa, MD, PhD | NTNU |
More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01419145 History of Changes |
| Other Study ID Numbers: | 2010/2620 (REK), 2010-022897-14 |
| Study First Received: | August 16, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Medicines Agency |
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:
|
Cachexia Emaciation Weight Loss Body Weight Changes Body Weight |
Signs and Symptoms Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013