Clinical trial NCT02871284: Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training
Official title: Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Chemotherapy-induced Polyneuropathy
Keywords: cancer
anticancer treatment
exercise
physical activity
sensorimotor training
chemotherapy-induced polyneuropathy
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: National Center for Tumor Diseases, Heidelberg
First posted: 2016-08-18
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.

There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.

Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 \& FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.


Eligibility criteria: Inclusion Criteria:

diagnosed with cancer and assigned to receive a chemotherapeutic regimen containing at least one of the following agents:

* a platinum analog, e.g., cisplatin, carboplatin, oxaliplatin
* a vinca alkaloid, e.g., vincristine
* a taxane, e.g., paclitaxel, docetaxel
* suramin
* thalidomide or lenalidomide
* bortezomib

Physical capability that allows the performance of the training program implemented within the experimental intervention or the control intervention arm

Exclusion Criteria:

* Known polyneuropathy of any kind or any polyneuropathic signs or symptoms at baseline
* Abnormal electroneurographic findings at baseline
* Known metastasis to the central or peripheral nervous system
* Any physical or mental handicap that would hamper the performance of the training program implemented within the intervention arms
* Family history positive for any hereditary polyneuropathy
* Known history of alcohol or illegal drug abuse or any constellation of lab values suggesting alcoholism

Primary outcomes:
measure: Total Neuropathy Scale (TNS)
timeFrame: up to week 24 (and 3 & 6 month follow up)
Secondary outcomes:
measure: Centre of Pressure (COP)
timeFrame: up to week 24 (and 3 & 6 month follow up)
measure: Strength Performance
timeFrame: up to week 24
measure: Cardiopulmonary Fitness
timeFrame: up to week 24 (and 3 & 6 month follow up)
measure: EORTC QLQ-C30
timeFrame: up to week 24 (and 3 & 6 month follow up)
measure: EORTC QLQ-CIPN20
timeFrame: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
measure: FACT-GOG-Ntx
timeFrame: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: up to week 24 (and 3 & 6 month follow up)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to week 24 (and 3 & 6 month follow up)
measure: Short QUestionnaire to ASsess Health-enhancing Physical Activity
timeFrame: up to week 24 (and 3 & 6 month follow up)
Other outcomes:
measure: Safety of exercise interventions
timeFrame: up to week 24
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Diseases
Study officials:
References:
citation: Muller J, Weiler M, Schneeweiss A, Haag GM, Steindorf K, Wick W, Wiskemann J. Preventive effect of sensorimotor exercise and resistance training on chemotherapy-induced peripheral neuropathy: a randomised-controlled trial. Br J Cancer. 2021 Sep;125(7):955-965. doi: 10.1038/s41416-021-01471-1. Epub 2021 Jul 5.