NeuroLight 2: Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: PBM1 group The patients allocated to the first PBM-group will receive twelve PBM sessions of 6 J/cm² over six weeks (2x/week). |
Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
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.
|
| Experimental: Experimental: PBM2 group The patients allocated to the second PBM-group will receive twelve PBM sessions of 8 J/cm² over six weeks (2x/week). |
Device: Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
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.
|
Outcome Measures
Primary Outcome Measures
- Modified total neuropathy score (mTNS) [Baseline]
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.
- Modified total neuropathy score (mTNS) [End of PBM (six weeks post-baseline)]
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.
- Modified total neuropathy score (mTNS) [Three weeks post-PBM]
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.
- Pain score [Baseline]
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.
- Pain score [End of PBM (six weeks post-baseline)]
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.
- Pain score [Three weeks post-PBM]
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.
- Mobility score [Baseline]
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.
- Mobility score [End of PBM (six weeks post-baseline)]
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.
- Mobility score [Three weeks post-PBM]
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.
Secondary Outcome Measures
- Quality of life score [Baseline]
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.
- Quality of life score [End of PBM (six weeks post-baseline)]
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.
- Quality of life score [Three weeks post-PBM]
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.
- Satisfaction score [Baseline]
The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).
- Satisfaction score [End of PBM (six weeks post-baseline)]
The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).
- satisfaction score [Three weeks post-PBM]
The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).
Other Outcome Measures
- General patient-, disease-, and treatment-related information [Baseline]
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).
- General patient-, disease-, and treatment-related information [End of PBM (six weeks post-baseline)]
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).
- General patient-, disease-, and treatment-related information [Three weeks post-PBM]
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).
- Cancer relapse or recurrence [One year post chemotherapy]
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
- Cancer relapse or recurrence [Two year post chemotherapy]
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
- Cancer relapse or recurrence [Three year post chemotherapy]
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
- Cancer relapse or recurrence [Four year post chemotherapy]
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
- Cancer relapse or recurrence [Five year post chemotherapy]
The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
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Diagnosed with CIPN
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Age 18 years or above
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Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
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Dutch-speaking
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Signed informed consent
Exclusion Criteria:
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Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
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Severe or unstable cardio- respiratory or musculoskeletal disease
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Interruption of more than two consecutive laser treatments
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Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jessa Hospital | Hasselt | Limburg | Belgium | 3500 |
Sponsors and Collaborators
- Jessa Hospital
Investigators
- Principal Investigator: Jeroen mebis, Prof. Dr., Jessa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023/007