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.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  Whole-body vibration on the background of an IP may improve physical fitness and coordination in patients suffering from CIPN.Trial registrationRetrospectively registered at http://www.iscrtn.com (ISRCTN 51361937) and http://www.clinicaltrials.gov (NCT02846844).
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Stefan S
authors.initials: SS
authors.lastname: Schönsteiner
authors.affiliation: VIV-ARTE®Bewegungsschule, Asselfingen, Germany.
authors.forename: Heidi
authors.initials: H
authors.lastname: Bauder Mißbach
authors.affiliation: German Cancer Research Center Heidelberg, Heidelberg, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Benner
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Silja
authors.initials: S
authors.lastname: Mack
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hamel
authors.affiliation: Department of Neurology, University Hospital Ulm, Ulm, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Orth
authors.affiliation: Department of Neurology, University Hospital Ulm, Ulm, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Landwehrmeyer
authors.affiliation: Department of Neurology, University Hospital Ulm, Ulm, Germany.
authors.forename: Sigurd D
authors.initials: SD
authors.lastname: Süßmuth
authors.affiliation: Department of Neurology, University Hospital Ulm, Ulm, Germany.
authors.forename: Carolin
authors.initials: C
authors.lastname: Geitner
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Regine
authors.initials: R
authors.lastname: Mayer-Steinacker
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Anneliese
authors.initials: A
authors.lastname: Riester
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Prokein
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Elfriede
authors.initials: E
authors.lastname: Erhardt
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Jelena
authors.initials: J
authors.lastname: Kunecki
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Eisenschink
authors.affiliation: Novotec Medical GmbH, Pforzheim, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Rawer
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Döhner
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kirchner
authors.affiliation: Department of Internal Medicine III, University Hospital Ulm, Albert Einstein Allee 23, 89081 Ulm, Germany.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Schlenk
keywords: Chemotherapy associated side effects; Chemotherapy related peripheral neuropathy; Integrated training program; Whole body vibration training