The Influence of Chemotherapy on Position Sense

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKU Leuven

About this trial

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most prevalent side-effects of chemotherapy, causing sensory and motor symptoms in patients. CIPN development is especially prevalent in chemotherapy treatment involving platinum- and taxane-based agents. The accompanying pain and deficits greatly impact the quality of life of these patients. Currently, patients are assessed for altered somatosensory using quantitative sensory testing (QST). The German Research Network on Neuropathic Pain (DFNS) has developed a standardized protocol which has been internationally recognized as approach for performing the QST. However, for proprioception the QST is limited to vibration assessments, making it limited as the only test to measure proprioception. Therefore, a comprehensive assessment of the proprioceptive functions is needed to better understand the influence CIPN has on the proprioception of patients, and thereby their quality of life.

In this project the effects of chemotherapy on somatosensory and proprioceptive functioning of breast cancer patients will be assessed in a cross-sectional study. This will be tested by comparing two groups of breast cancer patients and a healthy control group. Both patient groups will have undergone surgery for breast cancer, however, only one group will be tested after undergoing additional chemotherapy treatment. Thereby, the effects of chemotherapy between the surgery-only patient group and the chemotherapy patient group can tested. Furthermore, the investigators will compare both patient groups to sex- and age-matched healthy controls.

Eligibility criteria

Qualifiers

At least 18 years of age at the time of signing the informed consent form

Voluntary written informed consent of the participant has been obtained prior to any screening procedures

The patient is an adult oncological person between 18 and 75 years old who has been treated for cancer

The participant has undergone breast cancer surgery but has not received any radiotherapy or chemotherapy treatment (yet).

Disqualifiers

Participant has a history of mental or physical disorders or neurological disease beyond those related to cancer treatments.

Participant uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study.

Participant is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks which, in the investigator's opinion, might confound the results of the study.

Participant suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients).

Trial design

Treatments tested in this trial

  • Questionnaire - Edinburgh Handedness Assessment
  • Questionnaire - QuickDash
  • Questionnaire - EORTC QLQ-CIPN20
  • Questionnaire - Brief Pain Inventory (BPI)
  • Questionnaire - Multidimensional Fatigue Inventory (MFI-20)
  • Assessment of cognitive function - Montreal Cognitive Assessment (MoCA)
  • Assessment of cognitive function - Spatial working memory task
  • Robotic assessment of motor control - Visually guided reaching task
  • Robotic assessment of proprioception - Bilateral whole arm position matching task
  • Robotic assessment of proprioception - Whole arm perceptual boundary task
  • Robotic assessment of proprioception - Perturbation task
  • Robotic assessment of proprioception - Integration of vision and proprioception
  • Robotic assessment of proprioception - Force matching
  • Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task
  • Video-based assessment of proprioception - Finger-to-finger reaching task
  • Assessment of fatigue - Visual analogue scale
  • Assessment of fear of movement - Visual analogue scale
  • QST assessment of sensory function - Mechanical detection threshold
  • QST assessment of sensory function - Mechanical pain threshold
  • QST assessment of sensory function - Vibration detection threshold
  • Assessment of sensory function - Bumps
  • Assessment of range of motion
  • Assessment of total relative arm volume - Arm volume
  • Assessment of total relative arm volume - Hand volume

Treatment groups

145 Participants
are divided into 3 treatment groups

Sponsors and collaborators

KU Leuven

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator