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| ID | Type | Description | Link |
|---|---|---|---|
| Edge 3857 | Other Identifier | UZ Antwerpen (UZA) | |
| S69491 | Other Identifier | UZ/KU Leuven |
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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Kom Op Tegen Kanker | OTHER |
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Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.
The scientific goals of the project are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise intervention | Experimental | Participants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment) |
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| No formal exercise intervention | No Intervention | Standard of care (advice on physical activity during cancer treatment) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity | To evaluate the primary outcome sensory symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20 sensory subscale, score range from 9 to 36, higher scores indicating more sensory symptoms or problems). | at 12 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity | To evaluate the sensory, motor and autonomic symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20). Each subscale score will be linearly transformed to a 0-100 scale with higher scores indicating greater symptom burden. | at 4, 8, 12 and 24 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance - adherence to exercise intervention | Evaluated with a self-composed questionnaire. | From enrollment to the end of the intervention period at 12 weeks |
| Beliefs about the efficacy of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lore Dams | Contact | +32 3 265 16 59 | lore.dams@uantwerpen.be | |
| Prof. An De Groef | Contact | an.degroef@uantwerpen.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | 2650 | Belgium |
The data are not openly available and are available from the principal investigator upon reasonable request.
On request
On request
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Relative dose intensity chemotherapy (%) | Relative Dose Intensity (RDI) of chemotherapy, calculated as the ratio of delivered dose intensity to the planned dose intensity, expressed as a percentage. | at 4, 8, 12 and 24 weeks follow-up |
| Chemotherapy-induced peripheral neuropathy (CIPN) signs | The Total Neuropathy Score clinical version (TNSc) is used to evaluate motor symptoms, pin sensation, vibration sensibility, tendon reflexes and strength in the hands and feet (score range 0-20, higher scores indicating greater severity of neuropathy). | at 12 and 24 weeks follow-up |
| Pain severity hands and feet | Pain severity in the hands and feet will be evaluated with a Visual Analogue Scale (VAS). Four VAS scales will be completed: pain intensity at the present moment, mean pain intensity (global average pain intensity over the past week), maximum pain intensity (pain intensity at its maximum over the past week) and minimum pain intensity (pain intensity at its minimum over the past week). | at 12 and 24 weeks follow-up |
| General pain location and interference | Pain location and pain interference will be evaluated with the Brief Pain Inventory (BPI), including a body diagram to identify painful body areas and a pain interference section measuring how pain impacts various aspects of daily life, including mood, sleep, work and social activities (score range 0-70, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Physical functioning | Evaluated with the PROMIS Short Form v2.0 Physical Function 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). | at 12 and 24 weeks follow-up |
| Self-reported physical activity | Self-reported levels of physical activity are measured using the Godin-Shephard Leisure-Time Physical Activity Questionnaire. | at 12 and 24 weeks follow-up |
| Objective physical activity | Minutes spent in different intensity zones (sedentary, light, moderate, vigorous) will be collected using a Fitbit device. | at 12 and 24 weeks follow-up |
| Fatigue | Evaluated with the Multidimensional Fatigue Inventory (score range 20-100, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Sleep disturbance | Evaluated with the PROMIS Short Form v1.0 Sleep Disturbance 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Depression | Evaluated with the PROMIS Short Form v1.0 Depression 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Anxiety | Evaluated with the PROMIS Short Form v1.0 Anxiety 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Social participation | Evaluated with the PROMIS Short Form v2.0 Ability to participate in social roles and activities 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). | at 12 and 24 weeks follow-up |
| Support | Evaluated with the PROMIS Short Form v2.0 Emotional support 4a, PROMIS Short Form v2.0 Instrumental support 4a and PROMIS Short Form v2.0 Informational support 4a questionnaires (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). | at 12 and 24 weeks follow-up |
| Cognitive function | Evaluated with the Cognitive Failure Questionnaire (score range 0-100, higher scores mean a worse outcome). | at 12 and 24 weeks follow-up |
| Health-related quality of life | Evaluated with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire, including the index score (based on the Belgian value set) and the EQ VAS (range 0-100), with higher scores indicating better health outcomes. | at 12 and 24 weeks follow-up |
Evaluated with the Patient Global Impression of Change questionnaire (score range 1-7, higher scores mean a worse outcome).
| at 12 weeks follow-up |
| Safety of exercise intervention | Evaluated with a self-composed questionnaire. | From enrollment to the end of the intervention period at 12 weeks |
| Patient experiences with exercise intervention | Evaluated with a self-composed questionnaire. | at 4, 8, 12 and 24 weeks follow-up |
| Medication use | Self-composed questionnaire. | at 4, 8, 12 and 24 weeks follow-up |
| Body Mass Index (BMI) | BMI (kg/m²) will be calculated based on height (measured using a stadiometer) and weight (measured with the InBody 770 device). | at 12 and 24 weeks follow-up |
| Body composition - Extracellular water ratio | The extracellular water to total body water ratio (ECW/TBW ratio) will be assessed using the InBody 770 bioimpedance analyzer. | at 12 and 24 weeks follow-up |
| University Hospital Leuven | Recruiting | Leuven | 3000 | Belgium |
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