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This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: PBM1 group | Experimental | The patients allocated to the first PBM-group will receive twelve PBM sessions of 6 J/cm² over six weeks (2x/week). |
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| Experimental: PBM2 group | Experimental | The patients allocated to the second PBM-group will receive twelve PBM sessions of 8 J/cm² over six weeks (2x/week). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy) | Device | MLS® Laser M6 is a PBM device that allows the patients to be treated in various positions, either sitting, lying down or at a distance, without risk of contamination. Treatment times are carefully calibrated to deliver the best possible energy dose to the tissue being treated. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified total neuropathy score (mTNS) | The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy. | Baseline |
| Modified total neuropathy score (mTNS) | The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy. | End of PBM (six weeks post-baseline) |
| Modified total neuropathy score (mTNS) | The mTNS is a clinically applicable, sensitive screening tool for CIPN. The score ranges from 0 to 24, with a higher score indicating a higher level of neuropathy. | Three weeks post-PBM |
| Pain score | The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain. | Baseline |
| Pain score | The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain. | End of PBM (six weeks post-baseline) |
| Pain score | The patients' pain due to CIPN will be evaluated by using a numerical rating scale (NRS). The score ranges from 0 to 10, with a higher score indicating a higher level of pain. | Three weeks post-PBM |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeroen Mebis, Prof. Dr. | Contact | 011 33 72 21 | +32 | jeroen.mebis@jessazh.be |
| Marithé Claes, MSc | Contact | 011 33 72 39 | +32 | marithe.claes@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen mebis, Prof. Dr. | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| Mobility score |
The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI. |
| Baseline |
| Mobility score | The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI. | End of PBM (six weeks post-baseline) |
| Mobility score | The mobility of the patients will be measured using the six minute walk test. This test measures the distance the patient can walk in six minutes and compares it to the normal value for their age and BMI. | Three weeks post-PBM |
| Quality of life score |
The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life. |
| End of PBM (six weeks post-baseline) |
| Quality of life score | The Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT/GOG-NTX) is a validated patient questionnaire to test the quality of life of the patients with CIPN. The score ranges from 0 to 152, with a higher score indicating a lower quality of life. | Three weeks post-PBM |
| Satisfaction score | The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score). | Baseline |
| Satisfaction score | The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score). | End of PBM (six weeks post-baseline) |
| satisfaction score | The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score). | Three weeks post-PBM |
| General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | End of PBM (six weeks post-baseline) |
| General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | Three weeks post-PBM |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | One year post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Two year post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Three year post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Four year post chemotherapy |
| Cancer relapse or recurrence | The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records. | Five year post chemotherapy |