NCT01419145

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable cancer

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

August 16, 2011

Last Update Submit

June 15, 2017

Conditions

CancerCachexia

Keywords

cachexianeoplasmscomplicationscombined modality therapyexercise therapydiet therapyanti-inflammatory agents

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Multimodal intervention

EXPERIMENTAL
Other: Multimodal intervention

Standard Care

ACTIVE COMPARATOR
Other: Standard care

Interventions

Multimodal interventionOTHER

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.

Multimodal intervention
Standard careOTHER

Standard cancer care

Standard Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Oslo University Hospital Ullevål

Oslo, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28614627RESULT

  • 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.

    PMID: 33585533DERIVED

  • 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.

    PMID: 31816924DERIVED

MeSH Terms

Conditions

NeoplasmsCachexia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Stein Kaasa, MD, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Ken Fearon, MD, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

GB(1)NO(2)