Table 1

Standard Protocol Items: Recommendations for Interventional Trials flowchart—schedule of enrolment, interventions and assessments

TimepointStudy period
EnrolmentAllocationPostallocationClose-out
−t1 0t0 t1 t2 t3-5 t6
Enrolment
 Eligibility screenX
 Informed consentX
 AllocationX
Interventions
 Whole-body vibration training (12 weeks) Embedded Image
 Control group
  (12 weeks)
Embedded Image
 Follow-up
  (12 weeks, no training, both groups)
Embedded Image
Assessments
 Anamnesis (entity, stadium, pretreatment, prediseases, CIPN relevant medication, allergies, neurological and social anamnesis)X
 Nerve conduction studiesX
 Reported severity of CIPN-induced symptoms (FACT/GOG-Ntx)XXXXX
 Neurological clinical test batteryXXX
 Static and dynamic postural controlXXX
 Questionnaires (physical activity, EORTC-QLQ-C 30, EORTC-QLQ-CIPN20)XXX
 Visual analogue scale (neuropathic pain, dysesthesias)XXX
  • CIPN, chemotherapy-induced peripheral neuropathy; EORTC-QLQ-C,  European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC-QLQ-CIPN,  European Organization for Research and Treatment of Cancer peripheral neuropathy questionnaire; FACT/GOG-Ntx, Functional Assessment of Cancer Therapy/Gynaecology Oncology Group—Neurotoxicity.