Cargando…
A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises
BACKGROUND: Chemotherapy-induced polyneuropathy (CIPN) is a common toxicity after chemotherapy, immunomodulatory drugs or proteasome inhibitors, which is difficult to treat and may also have impact on quality of life. The objective of the study was to evaluate whole-body vibration (WBV) on the backg...
Autores principales: | , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297221/ https://www.ncbi.nlm.nih.gov/pubmed/28194306 http://dx.doi.org/10.1186/s40164-017-0065-6 |
_version_ | 1782505701879316480 |
---|---|
author | Schönsteiner, Stefan S. Bauder Mißbach, Heidi Benner, Axel Mack, Silja Hamel, Thomas Orth, Michael Landwehrmeyer, Bernhard Süßmuth, Sigurd D. Geitner, Carolin Mayer-Steinacker, Regine Riester, Anneliese Prokein, Andrea Erhardt, Elfriede Kunecki, Jelena Eisenschink, Anna M. Rawer, Rainer Döhner, Hartmut Kirchner, Elisabeth Schlenk, Richard F. |
author_facet | Schönsteiner, Stefan S. Bauder Mißbach, Heidi Benner, Axel Mack, Silja Hamel, Thomas Orth, Michael Landwehrmeyer, Bernhard Süßmuth, Sigurd D. Geitner, Carolin Mayer-Steinacker, Regine Riester, Anneliese Prokein, Andrea Erhardt, Elfriede Kunecki, Jelena Eisenschink, Anna M. Rawer, Rainer Döhner, Hartmut Kirchner, Elisabeth Schlenk, Richard F. |
author_sort | Schönsteiner, Stefan S. |
collection | PubMed |
description | BACKGROUND: Chemotherapy-induced polyneuropathy (CIPN) is a common toxicity after chemotherapy, immunomodulatory drugs or proteasome inhibitors, which is difficult to treat and may also have impact on quality of life. The objective of the study was to evaluate whole-body vibration (WBV) on the background of an integrated program (IP) including massage, passive mobilization and physical exercises on CIPN. PATIENTS AND METHODS: In an exploratory phase-2 study patients with CIPN (NCI CTC grade 2/3) were randomized for WBV plus IP (experimental) to IP alone (standard). 15 training sessions within 15 weeks were intended. As primary endpoint we used chair-rising test (CRT) to assess physical fitness and coordination. In addition, locomotor and neurological tests and self-assessment tools were performed. RESULTS: A total 131 patients with CIPN were randomized (standard, n = 65; experimental, n = 66). The median age was 60 (range 24–71) years; 44 patients had haematological neoplasms and 87 solid tumors. At baseline, all patients presented with an abnormal CRT. Fifteen (standard) and 22 (experimental) patients left the program due to progression/relapse or concomitant disease. There was no significant difference in the proportion of patients with normal CRT (<10 s) at follow up between experimental (68%) and standard (56%) (p = 0.20). All patients experienced less symptoms and pain (p < 0.001) and had improved CRT (p < 0.001) over time. WBV was significantly associated with a higher reduction of time needed for CRT (p = 0.02) and significantly improved warm-detection-threshold comparing baseline to follow-up assessment (p = 0.02). CONCLUSION: Whole-body vibration on the background of an IP may improve physical fitness and coordination in patients suffering from CIPN. Trial registration Retrospectively registered at http://www.iscrtn.com (ISRCTN 51361937) and http://www.clinicaltrials.gov (NCT02846844). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40164-017-0065-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5297221 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-52972212017-02-13 A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises Schönsteiner, Stefan S. Bauder Mißbach, Heidi Benner, Axel Mack, Silja Hamel, Thomas Orth, Michael Landwehrmeyer, Bernhard Süßmuth, Sigurd D. Geitner, Carolin Mayer-Steinacker, Regine Riester, Anneliese Prokein, Andrea Erhardt, Elfriede Kunecki, Jelena Eisenschink, Anna M. Rawer, Rainer Döhner, Hartmut Kirchner, Elisabeth Schlenk, Richard F. Exp Hematol Oncol Research BACKGROUND: Chemotherapy-induced polyneuropathy (CIPN) is a common toxicity after chemotherapy, immunomodulatory drugs or proteasome inhibitors, which is difficult to treat and may also have impact on quality of life. The objective of the study was to evaluate whole-body vibration (WBV) on the background of an integrated program (IP) including massage, passive mobilization and physical exercises on CIPN. PATIENTS AND METHODS: In an exploratory phase-2 study patients with CIPN (NCI CTC grade 2/3) were randomized for WBV plus IP (experimental) to IP alone (standard). 15 training sessions within 15 weeks were intended. As primary endpoint we used chair-rising test (CRT) to assess physical fitness and coordination. In addition, locomotor and neurological tests and self-assessment tools were performed. RESULTS: A total 131 patients with CIPN were randomized (standard, n = 65; experimental, n = 66). The median age was 60 (range 24–71) years; 44 patients had haematological neoplasms and 87 solid tumors. At baseline, all patients presented with an abnormal CRT. Fifteen (standard) and 22 (experimental) patients left the program due to progression/relapse or concomitant disease. There was no significant difference in the proportion of patients with normal CRT (<10 s) at follow up between experimental (68%) and standard (56%) (p = 0.20). All patients experienced less symptoms and pain (p < 0.001) and had improved CRT (p < 0.001) over time. WBV was significantly associated with a higher reduction of time needed for CRT (p = 0.02) and significantly improved warm-detection-threshold comparing baseline to follow-up assessment (p = 0.02). CONCLUSION: Whole-body vibration on the background of an IP may improve physical fitness and coordination in patients suffering from CIPN. Trial registration Retrospectively registered at http://www.iscrtn.com (ISRCTN 51361937) and http://www.clinicaltrials.gov (NCT02846844). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40164-017-0065-6) contains supplementary material, which is available to authorized users. BioMed Central 2017-02-07 /pmc/articles/PMC5297221/ /pubmed/28194306 http://dx.doi.org/10.1186/s40164-017-0065-6 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Schönsteiner, Stefan S. Bauder Mißbach, Heidi Benner, Axel Mack, Silja Hamel, Thomas Orth, Michael Landwehrmeyer, Bernhard Süßmuth, Sigurd D. Geitner, Carolin Mayer-Steinacker, Regine Riester, Anneliese Prokein, Andrea Erhardt, Elfriede Kunecki, Jelena Eisenschink, Anna M. Rawer, Rainer Döhner, Hartmut Kirchner, Elisabeth Schlenk, Richard F. A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title | A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title_full | A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title_fullStr | A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title_full_unstemmed | A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title_short | A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
title_sort | randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297221/ https://www.ncbi.nlm.nih.gov/pubmed/28194306 http://dx.doi.org/10.1186/s40164-017-0065-6 |
work_keys_str_mv | AT schonsteinerstefans arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT baudermißbachheidi arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT benneraxel arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT macksilja arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT hamelthomas arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT orthmichael arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT landwehrmeyerbernhard arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT sußmuthsigurdd arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT geitnercarolin arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT mayersteinackerregine arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT riesteranneliese arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT prokeinandrea arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT erhardtelfriede arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT kuneckijelena arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT eisenschinkannam arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT rawerrainer arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT dohnerhartmut arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT kirchnerelisabeth arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT schlenkrichardf arandomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT schonsteinerstefans randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT baudermißbachheidi randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT benneraxel randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT macksilja randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT hamelthomas randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT orthmichael randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT landwehrmeyerbernhard randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT sußmuthsigurdd randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT geitnercarolin randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT mayersteinackerregine randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT riesteranneliese randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT prokeinandrea randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT erhardtelfriede randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT kuneckijelena randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT eisenschinkannam randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT rawerrainer randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT dohnerhartmut randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT kirchnerelisabeth randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises AT schlenkrichardf randomizedexploratoryphase2studyinpatientswithchemotherapyrelatedperipheralneuropathyevaluatingwholebodyvibrationtrainingasadjuncttoanintegratedprogramincludingmassagepassivemobilizationandphysicalexercises |