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

Conditions

Cachexia, Cancer

Keywords

cachexia, neoplasms, complications, combined modality therapy, exercise therapy, diet therapy, anti-inflammatory agents

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.

Trude R. Balstad, Cinzia Brunelli, Caroline Hild Hakvåg Pettersen, Svanhild A. Schønberg, Frank Skorpen et al. (11 authors)

Frontiers in Nutrition2021-01-1414 citations

10.3389/fnut.2020.602775

Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia

Guro B. Stene, Trude R. Balstad, Anne Silja Mäkitalo Leer, Asta Bye, Stein Kaasa et al. (9 authors)

Cancers2019-12-0327 citations

10.3390/cancers11121925

Unfavorable impact of cancer cachexia on activity of daily living and need for inpatient care in elderly patients with advanced non-small-cell lung cancer in Japan: a prospective longitudinal observational study.

Naito T, Okayama T, Aoyama T, Ohashi T, Masuda Y, Kimura M, Shiozaki H, Murakami H, Kenmotsu H, Taira T, Ono A, Wakuda K, Imai H, Oyakawa T, Ishii T, Omori S, Nakashima K, Endo M, Omae K, Mori K, Yamamoto N, Tanuma A, Takahashi T.

2017-11-2844 citations

10.1186/s12885-017-3795-2

Skeletal muscle depletion during chemotherapy has a large impact on physical function in elderly Japanese patients with advanced non-small-cell lung cancer.

Naito T, Okayama T, Aoyama T, Ohashi T, Masuda Y, Kimura M, Shiozaki H, Murakami H, Kenmotsu H, Taira T, Ono A, Wakuda K, Imai H, Oyakawa T, Ishii T, Omori S, Nakashima K, Endo M, Omae K, Mori K, Yamamoto N, Tanuma A, Takahashi T.

2017-08-2555 citations

10.1186/s12885-017-3562-4

A randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Anti-inflammatory Medication) plus standard care versus standard care alone to prevent / attenuate cachexia in advanced cancer patients undergoing chemotherapy.

Stein Kaasa, Tora S. Solheim, Barry Laird, Trude R. Balstad, Guro B. Stene et al. (9 authors)

Journal of Clinical Oncology2015-05-2019 citations

10.1200/jco.2015.33.15_suppl.9628

Interventions

OTHERMultimodal 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.

OTHERStandard care

Standard cancer care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of recruitment and retention	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.

Countries

Norway, United Kingdom

Outcome results

None listed