Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy

NCT05606588 | Recruiting DMC

• 1 other identifier: 2021-00527
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators would like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients will be recruited from 7 centers (CH/D). All patients (and their guardians) scheduled to receive chemotherapy containing either a platinum derivate or vinca-alkaloid, will be asked to participate. Willing patients will then be randomized either into an intervention group or a control group. Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after therapy. Data will be assessed at 3-4 time points: Prior to chemotherapy (baseline T0), after 12 weeks (T1), after completion of therapy for children that are treated \>3 months (Tp) and after 12 months follow-up (T3). Additionally, status of Chemotherapy-induced peripheral neuropathy (CIPN) reported symptoms will be monitored twice in-between (6 weeks). The investigators hypothesize that less children in the intervention group will develop symptoms of CIPN (TNS score) with its debilitating side-effects. Furthermore, children in the intervention group will be able to maintain relevant motor and sensory functions and their associated physical functions which will enable them to receive their planned medical therapy but also to stay on the age-appropriate motor development level, improve their quality life and enhance social reintegration after therapy.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Pediatric Cancer

Keywords

Cancer; Lymphoma; Leukemia; Non-Hodgkin Lymphoma; Children; Exercise; Chemotherapy-induced peripheral neuropathy; CIPN; Sensorimotor Training

Outcome Measures

Primary Outcomes (2)

• Pre-/Post incidence of neuropathic symptoms via Ped-mTNS score

  Primary endpoint is the Ped-mTNS score. It contains a short questionnaire as well as a clinical test battery. The questionnaire is composed of three sets of questions on sensory symptoms and pain, motor function, and autonomic function, and a five- part neurologic exam. The clinical test battery contains light touch sensation, evaluated with Semmes-Weinstein-monofilaments, pin sensibility (MediPin), vibration sensibility assessed with a biothesiometer, deep tendon reflexes of Achilles and patellar tendons and muscular strength examined by a manual muscle test36, each category is rated on a likert scale from 0-4 (0 indicating no symptoms and 4 severe symptoms).

  Baseline (T0), subjective screening for symptoms of CIPN (via phone cell), 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 Months (TFU)

• Pre/Post change of signs and symptoms of a neuropathy (VAS (0-10))

  Signs and symptoms of CIPN

  Baseline (T0), Screening for symptoms of CIPN (via phone cell), 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 Months (TFU)

Secondary Outcomes (9)

• Secondary Outcomes - Pre/post change of postural control

  Baseline (T0), after 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 months after last dose of Chemotherapy (TFU)

• Pre/post change of Dorsiflexion

  Baseline (T0), after 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 months after last dose of Chemotherapy (TFU)

• Pre/post change of strength in the lower extremity - knee extension

  Baseline (T0), after 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 months after last dose of Chemotherapy (TFU)

• Pre/post change of lower limb power

  Baseline (T0), after 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 months after last dose of Chemotherapy (TFU)

• Pre/post change of gait speed

  Baseline (T0), after 12 weeks (T1), within 7days after last dosage of medical therapy (Tp), 12 months after last dose of Chemotherapy (TFU)

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, in addition to usual care.

Behavioral: Playful sensorimotor training

Control group

NO INTERVENTION

The control group receives treatment as usual. The control group will be given the opportunity to participate in the intervention after therapy.

Interventions

Playful sensorimotor training BEHAVIORAL

For the max. duration of the first in-hospital phase (3weeks), all children will receive supervised training. When children go home they will be supplied with a manual, specific exercises and the necessary training devices. Regular supervision will allow to ensure that the training is performed at maximum benefit. Each session will last for about 20 to 30 minutes in total, including a child-specific warm-up and cool-down. The children will be asked to maintain balance in a previously acquired "short-foot-position", knees slightly flexed (30°), without shoes. Training will consist of 5 playful balance exercises chosen from a standardized pool of exercises according to the child's age, with increasing difficulty in order to allow for individual, optimal progression. Each of the 5 exercises will contain of 5 repetitions for 10sec. allowing for a 20sec. rest in between each set and a 1min rest between each exercise in order to avoid neural fatigue.

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All tumor patients, aged 6-18 years, who are scheduled to receive neurotoxic chemotherapy with a platinum-derivate or vinca- alkaloid (e.g. vincristine, vinblastin mono, carboplatinum, cisplatin).

Sponsors & Collaborators

• University of Basel: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Kantonsspital Aarau: collaborator
• Ostschweizer Kinderspital: collaborator
• University Hospital Heidelberg: collaborator
• University Hospital Freiburg: collaborator
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• Charite University, Berlin, Germany: collaborator
• National Center for Tumor Diseases, Heidelberg: collaborator

Study Sites (2)

Kantonspital Aarau

Basel, 4056, Switzerland

NOT YET RECRUITING

UKBB Kinderspital

Basel, 4056, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasms; Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Behavior

Study Officials

• Fiona Streckmann, Dr.

  University of Basel, Department of Sport, Exercise and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Streckmann, Dr.

CONTACT

061 207 47 30; fiona.streckmann@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessors will be blinded and participants will only be told the result of their randomization after the baseline assessment. For the following assessments patients and guardians will be instructed prior to the assessment not to reveal the arm they are in. Assessors are instructed to converse as little as possible outside the friendly instructions. Assessors and trainers will participate in separate study meetings and cannot speak to each other regarding patient matters.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This study will follow a prospective, multicenter, two-armed, randomised, controlled, assessor-blinded trial trial (RCT with follow-up).

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: November 4, 2022
• Study Start: December 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available after completion of the study and publication of the first manuscript
• Access Criteria: on demand

Locations

CH (2)