Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training

NCT ID: NCT02871284

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Exercise; Chemotherapy-induced Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sensorimotor training (EI)

The participants of the experimental intervention arm will take part in a 45 minutes sensorimotor training class two times a week for a maximum of 24 weeks at the NCT (National Center for Tumor Diseases). Highly qualified exercise therapists will guide the class. Class size will be no bigger than 8 patients to ensure adequate individual supervision and guidance. Additionally, participants will be asked to perform one weekly 15 minutes home-based sessions without supervision. Participants who are not able to come to the NCT Heidelberg 2x/week will be offered a home-based sensorimotor program including the same exercises. At the beginning, participants will receive an appointment for an individual face-to-face counseling session at the NCT. During this appointment, the patient will receive an exercise manual for individualized home-based sensorimotor training and a practical introduction by the exercise therapist.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

machine-based resistance training (AC)

Participants of the active control arm will receive machine-based resistance training. The supervised resistance exercise program will be undertaken twice weekly in small groups (not more than 12 people per group) of participants and will be guided by an exercise physiotherapist over a maximum of 24 weeks. All sessions will start with a warm-up and finish with a cool-down (comprising exercise on a cycle ergometer or treadmill at a relatively low intensity and stretching activities) and will take approximately 45 minutes. Additionally, participants will be asked to perform a weekly 15 minutes home-based resistance training session without supervision

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

usual care

Participants will receive usual care with no additional exercise training or intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Center for Tumor Diseases

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34226683 (View on PubMed)

Other Identifiers

S-630/2015/PIC

Identifier Type: -

Identifier Source: org_study_id