Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study
Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study
BACKGROUND: A reduced exercise capacity is associated with increased morbidity and mortality in patients with advanced non-small cell lung cancer (NSCLC). Therapeutic exercise can be beneficial and neuromuscular electrical stimulation (NMES) of the quadriceps muscles may represent a practical approach. The primary aim of this study was to determine the acceptability of NMES of the quadriceps to patients with NSCLC used alongside palliative chemotherapy. Secondary aims explored aspects of safety and efficacy of NMES in this setting.
METHODS: Patients with advanced NSCLC due to receive first-line palliative chemotherapy were randomized to usual care with or without NMES. They were asked to undertake 30 minute sessions of NMES, ideally daily, but as a minimum, three times weekly. For NMES to be considered acceptable, it was predetermined that ≥80% of patients should achieve this minimum level of adherence. Qualitative interviews were held with a subset of patients to explore factors influencing adherence. Safety was assessed according to the Common Terminology Criteria for Adverse Events. Quadriceps muscle strength, thigh lean mass, and physical activity level were assessed at baseline and after three cycles of chemotherapy.
RESULTS: 49 patients (28 male, median (IQR) age 69 (64-75) years) participated. Of 30 randomized to NMES, 18 were eligible for the primary endpoint, of whom 9 (50% [90% CI, 29 to 71]) met the minimum level of adherence. Adherence was enhanced by incorporating sessions into a daily routine and hindered by undesirable effects of chemotherapy. There were no serious adverse events related to NMES, nor significant differences in quadriceps muscle strength, thigh lean mass or physical activity level between groups.
CONCLUSIONS: NMES is not acceptable in this setting, nor was there a suggestion of benefit. The need remains to explore NMES in patients with cancer in other settings.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN 42944026 www.controlled-trials.com/ISRCTN42944026.
Adrenal Cortex Hormones, Aged, Antineoplastic Agents, Hormonal, Carcinoma, Non-Small-Cell Lung, Electric Stimulation Therapy, Female, Humans, Lung Neoplasms, Male, Middle Aged, Muscle, Skeletal, Palliative Care, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
e86059
Maddocks, Matthew
33311e9a-383e-4824-8fed-524778230b1a
Halliday, Vanessa
758df212-19d3-4a83-8166-aa1fd689d63e
Chauhan, Alpna
1c29c6d6-08c4-47e6-9631-dd186a1fc3aa
Taylor, Victoria
8dedb6fd-a7e2-4e53-9f4a-d2a1c58ff1db
Nelson, Annmarie
9be17968-fda0-4bd8-94cd-96d772f5083c
Sampson, Cathy
f4e9783b-358f-44aa-ac8a-d77093bfd334
Byrne, Anthony
6ef79522-a36a-465b-9bd4-9bf24bc8cfbf
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Wilcock, Andrew
724d6c43-6d18-4c04-a072-5b56ccb13656
30 December 2013
Maddocks, Matthew
33311e9a-383e-4824-8fed-524778230b1a
Halliday, Vanessa
758df212-19d3-4a83-8166-aa1fd689d63e
Chauhan, Alpna
1c29c6d6-08c4-47e6-9631-dd186a1fc3aa
Taylor, Victoria
8dedb6fd-a7e2-4e53-9f4a-d2a1c58ff1db
Nelson, Annmarie
9be17968-fda0-4bd8-94cd-96d772f5083c
Sampson, Cathy
f4e9783b-358f-44aa-ac8a-d77093bfd334
Byrne, Anthony
6ef79522-a36a-465b-9bd4-9bf24bc8cfbf
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Wilcock, Andrew
724d6c43-6d18-4c04-a072-5b56ccb13656
Maddocks, Matthew, Halliday, Vanessa, Chauhan, Alpna, Taylor, Victoria, Nelson, Annmarie, Sampson, Cathy, Byrne, Anthony, Griffiths, Gareth and Wilcock, Andrew
(2013)
Neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer receiving palliative chemotherapy: a randomized phase II study.
PLoS ONE, 8 (12), .
(doi:10.1371/journal.pone.0086059).
Abstract
BACKGROUND: A reduced exercise capacity is associated with increased morbidity and mortality in patients with advanced non-small cell lung cancer (NSCLC). Therapeutic exercise can be beneficial and neuromuscular electrical stimulation (NMES) of the quadriceps muscles may represent a practical approach. The primary aim of this study was to determine the acceptability of NMES of the quadriceps to patients with NSCLC used alongside palliative chemotherapy. Secondary aims explored aspects of safety and efficacy of NMES in this setting.
METHODS: Patients with advanced NSCLC due to receive first-line palliative chemotherapy were randomized to usual care with or without NMES. They were asked to undertake 30 minute sessions of NMES, ideally daily, but as a minimum, three times weekly. For NMES to be considered acceptable, it was predetermined that ≥80% of patients should achieve this minimum level of adherence. Qualitative interviews were held with a subset of patients to explore factors influencing adherence. Safety was assessed according to the Common Terminology Criteria for Adverse Events. Quadriceps muscle strength, thigh lean mass, and physical activity level were assessed at baseline and after three cycles of chemotherapy.
RESULTS: 49 patients (28 male, median (IQR) age 69 (64-75) years) participated. Of 30 randomized to NMES, 18 were eligible for the primary endpoint, of whom 9 (50% [90% CI, 29 to 71]) met the minimum level of adherence. Adherence was enhanced by incorporating sessions into a daily routine and hindered by undesirable effects of chemotherapy. There were no serious adverse events related to NMES, nor significant differences in quadriceps muscle strength, thigh lean mass or physical activity level between groups.
CONCLUSIONS: NMES is not acceptable in this setting, nor was there a suggestion of benefit. The need remains to explore NMES in patients with cancer in other settings.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN 42944026 www.controlled-trials.com/ISRCTN42944026.
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More information
Accepted/In Press date: 28 November 2013
Published date: 30 December 2013
Keywords:
Adrenal Cortex Hormones, Aged, Antineoplastic Agents, Hormonal, Carcinoma, Non-Small-Cell Lung, Electric Stimulation Therapy, Female, Humans, Lung Neoplasms, Male, Middle Aged, Muscle, Skeletal, Palliative Care, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
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Local EPrints ID: 413011
URI: http://eprints.soton.ac.uk/id/eprint/413011
ISSN: 1932-6203
PURE UUID: 5cd6218f-df76-41cd-8966-b6f576c06baf
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Date deposited: 10 Aug 2017 16:31
Last modified: 16 Mar 2024 04:19
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Author:
Matthew Maddocks
Author:
Vanessa Halliday
Author:
Alpna Chauhan
Author:
Victoria Taylor
Author:
Annmarie Nelson
Author:
Cathy Sampson
Author:
Anthony Byrne
Author:
Andrew Wilcock
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