The Influence of Chemotherapy on Position Sense (ProprioCIPN)

Catholic University (KU) of Leuven

Status: Not yet enrolling

Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy; Chemotherapy-Induced Peripheral Neuropathy; Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT07367711

S70774

Details and patient eligibility

About

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.

Enrollment: 145 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

General (applies to all participants):

• 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

Breast cancer surgery-only patient group:

• 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).
• The first session takes place between two and six weeks after breast cancer surgery.
• The second session takes before any follow-up treatment for breast cancer (radiotherapy or chemotherapy).

Chemotherapy group:

• 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 (yet).
• Participant has a history of treatment with platinum- or taxane-based chemotherapeutic agents, and this treatment has been terminated no later than 6 weeks before the first session.

Healthy control group:

• No history of cancer or chemotherapy treatment
• Sex and age-matched to patient sample

Exclusion Criteria:

General (applies to all participants):

• 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).
• Participant has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain.
• If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive

Trial design

145 participants in 3 patient groups

Surgery only

Description:

Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.

Treatment:

Diagnostic Test: Robotic assessment of proprioception - Whole arm perceptual boundary task

Other: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA)

Behavioral: Assessment of fear of movement - Visual analogue scale

Diagnostic Test: Robotic assessment of motor control - Visually guided reaching task

Diagnostic Test: Robotic assessment of proprioception - Integration of vision and proprioception

Diagnostic Test: QST assessment of sensory function - Mechanical pain threshold

Other: Questionnaire - Brief Pain Inventory (BPI)

Other: Assessment of range of motion

Diagnostic Test: Robotic assessment of proprioception - Force matching

Diagnostic Test: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task

Other: Assessment of total relative arm volume - Hand volume

Behavioral: Assessment of fatigue - Visual analogue scale

Other: Assessment of total relative arm volume - Arm volume

Other: Assessment of cognitive function - Spatial working memory task

Other: Questionnaire - EORTC QLQ-CIPN20

Other: Questionnaire - Multidimensional Fatigue Inventory (MFI-20)

Diagnostic Test: Robotic assessment of proprioception - Bilateral whole arm position matching task

Diagnostic Test: Robotic assessment of proprioception - Perturbation task

Other: Questionnaire - Edinburgh Handedness Assessment

Diagnostic Test: Assessment of sensory function - Bumps

Other: Questionnaire - QuickDash

Diagnostic Test: Video-based assessment of proprioception - Finger-to-finger reaching task

Diagnostic Test: QST assessment of sensory function - Vibration detection threshold

Diagnostic Test: QST assessment of sensory function - Mechanical detection threshold

Surgery + Chemotherapy

Description:

Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.

Treatment:

Diagnostic Test: Robotic assessment of proprioception - Whole arm perceptual boundary task

Other: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA)

Behavioral: Assessment of fear of movement - Visual analogue scale

Diagnostic Test: Robotic assessment of motor control - Visually guided reaching task

Diagnostic Test: Robotic assessment of proprioception - Integration of vision and proprioception

Diagnostic Test: QST assessment of sensory function - Mechanical pain threshold

Other: Questionnaire - Brief Pain Inventory (BPI)

Other: Assessment of range of motion

Diagnostic Test: Robotic assessment of proprioception - Force matching

Diagnostic Test: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task

Other: Assessment of total relative arm volume - Hand volume

Behavioral: Assessment of fatigue - Visual analogue scale

Other: Assessment of total relative arm volume - Arm volume

Other: Assessment of cognitive function - Spatial working memory task

Other: Questionnaire - EORTC QLQ-CIPN20

Other: Questionnaire - Multidimensional Fatigue Inventory (MFI-20)

Diagnostic Test: Robotic assessment of proprioception - Bilateral whole arm position matching task

Diagnostic Test: Robotic assessment of proprioception - Perturbation task

Other: Questionnaire - Edinburgh Handedness Assessment

Diagnostic Test: Assessment of sensory function - Bumps

Other: Questionnaire - QuickDash

Diagnostic Test: Video-based assessment of proprioception - Finger-to-finger reaching task

Diagnostic Test: QST assessment of sensory function - Vibration detection threshold

Diagnostic Test: QST assessment of sensory function - Mechanical detection threshold

Healthy control

Description:

Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.

Treatment:

Diagnostic Test: Robotic assessment of proprioception - Whole arm perceptual boundary task

Other: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA)

Behavioral: Assessment of fear of movement - Visual analogue scale

Diagnostic Test: Robotic assessment of motor control - Visually guided reaching task

Diagnostic Test: Robotic assessment of proprioception - Integration of vision and proprioception

Diagnostic Test: QST assessment of sensory function - Mechanical pain threshold

Other: Questionnaire - Brief Pain Inventory (BPI)

Other: Assessment of range of motion

Diagnostic Test: Robotic assessment of proprioception - Force matching

Diagnostic Test: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task

Other: Assessment of total relative arm volume - Hand volume

Behavioral: Assessment of fatigue - Visual analogue scale

Other: Assessment of total relative arm volume - Arm volume

Other: Assessment of cognitive function - Spatial working memory task

Other: Questionnaire - EORTC QLQ-CIPN20

Other: Questionnaire - Multidimensional Fatigue Inventory (MFI-20)

Diagnostic Test: Robotic assessment of proprioception - Bilateral whole arm position matching task

Diagnostic Test: Robotic assessment of proprioception - Perturbation task

Other: Questionnaire - Edinburgh Handedness Assessment

Diagnostic Test: Assessment of sensory function - Bumps

Other: Questionnaire - QuickDash

Diagnostic Test: Video-based assessment of proprioception - Finger-to-finger reaching task

Diagnostic Test: QST assessment of sensory function - Vibration detection threshold

Diagnostic Test: QST assessment of sensory function - Mechanical detection threshold