A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer

Tora S Solheim, Barry J. A. Laird (Corresponding Author), Trude Rakel Balstad, Guro B. Stene, Asta Bye, Neil Johns, Caroline H Pettersen, Marie Fallon, Peter Fayers, Kenneth C H Fearon, Stein Kaasa

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Abstract

BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical func-tion. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim ofthis study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritionalsupplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung orpancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia inter-vention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance withintervention (>50% of components in>50% of patients). Key secondary outcomes were change in weight, muscle mass, phys-ical activity, safety, and survival.ResultsThree hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twentyfive patients wererandomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the indi-vidual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As ex-pected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were nointervention-related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer;however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effectof the intervention.
Original languageEnglish
Pages (from-to)778-788
Number of pages11
JournalJournal of Cachexia, Sarcopenia and Muscle
Volume8
Issue number5
Early online date14 Jun 2017
DOIs
Publication statusPublished - Oct 2017

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Cachexia
Pancreatic Neoplasms
Celecoxib
Lung Neoplasms
Exercise
Muscles
Safety
Drug Therapy
Survival
Omega-3 Fatty Acids
Anorexia
Sample Size
Compliance
Weight Loss
Anti-Inflammatory Agents
Fats
Outcome Assessment (Health Care)
Weights and Measures
Therapeutics
Neoplasms

Keywords

  • cachexia
  • cancer
  • randomised
  • multi-modal
  • trial
  • anti-inflammatory

Cite this

A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. / Solheim, Tora S; Laird, Barry J. A. (Corresponding Author); Balstad, Trude Rakel; Stene, Guro B.; Bye, Asta; Johns, Neil; Pettersen, Caroline H; Fallon, Marie; Fayers, Peter; Fearon, Kenneth C H; Kaasa, Stein.

In: Journal of Cachexia, Sarcopenia and Muscle, Vol. 8, No. 5, 10.2017, p. 778-788.

Research output: Contribution to journalArticle

Solheim, TS, Laird, BJA, Balstad, TR, Stene, GB, Bye, A, Johns, N, Pettersen, CH, Fallon, M, Fayers, P, Fearon, KCH & Kaasa, S 2017, 'A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer', Journal of Cachexia, Sarcopenia and Muscle, vol. 8, no. 5, pp. 778-788. https://doi.org/10.1002/jcsm.12201
Solheim, Tora S ; Laird, Barry J. A. ; Balstad, Trude Rakel ; Stene, Guro B. ; Bye, Asta ; Johns, Neil ; Pettersen, Caroline H ; Fallon, Marie ; Fayers, Peter ; Fearon, Kenneth C H ; Kaasa, Stein. / A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. In: Journal of Cachexia, Sarcopenia and Muscle. 2017 ; Vol. 8, No. 5. pp. 778-788.
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abstract = "BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical func-tion. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim ofthis study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritionalsupplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung orpancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia inter-vention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance withintervention (>50{\%} of components in>50{\%} of patients). Key secondary outcomes were change in weight, muscle mass, phys-ical activity, safety, and survival.ResultsThree hundred and ninety-nine were screened resulting in 46 patients recruited (11.5{\%}). Twentyfive patients wererandomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11{\%}). Compliance to the indi-vidual components of the intervention was 76{\%} for celecoxib, 60{\%} for exercise, and 48{\%} for nutritional supplements. As ex-pected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were nointervention-related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer;however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effectof the intervention.",
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AU - Solheim, Tora S

AU - Laird, Barry J. A.

AU - Balstad, Trude Rakel

AU - Stene, Guro B.

AU - Bye, Asta

AU - Johns, Neil

AU - Pettersen, Caroline H

AU - Fallon, Marie

AU - Fayers, Peter

AU - Fearon, Kenneth C H

AU - Kaasa, Stein

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N2 - BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical func-tion. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim ofthis study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritionalsupplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung orpancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia inter-vention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance withintervention (>50% of components in>50% of patients). Key secondary outcomes were change in weight, muscle mass, phys-ical activity, safety, and survival.ResultsThree hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twentyfive patients wererandomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the indi-vidual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As ex-pected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were nointervention-related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer;however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effectof the intervention.

AB - BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical func-tion. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim ofthis study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritionalsupplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung orpancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia inter-vention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance withintervention (>50% of components in>50% of patients). Key secondary outcomes were change in weight, muscle mass, phys-ical activity, safety, and survival.ResultsThree hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twentyfive patients wererandomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the indi-vidual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As ex-pected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were nointervention-related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer;however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effectof the intervention.

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