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NCT Number: NCT05763706

Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
  • Diagnosed with CIPN
  • Age 18 years or above
  • Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
  • Dutch-speaking
  • Signed informed consent

Exclusion criteria

  • Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
  • Severe or unstable cardio- respiratory or musculoskeletal disease
  • Interruption of more than two consecutive laser treatments
  • Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)

Treatment and study plan

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.

Primary outcomes

  1. Modified total neuropathy score (mTNS)

    Time frame: 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.

  2. Modified total neuropathy score (mTNS)

    Time frame: 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.

  3. Modified total neuropathy score (mTNS)

    Time frame: 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.

  4. Pain score

    Time frame: 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.

  5. Pain score

    Time frame: 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.

  6. Pain score

    Time frame: 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.

  7. Mobility score

    Time frame: 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.

  8. Mobility score

    Time frame: 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.

  9. Mobility score

    Time frame: 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 outcomes

  1. Quality of life score

    Time frame: 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.

  2. Quality of life score

    Time frame: 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.

  3. Quality of life score

    Time frame: 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.

  4. Satisfaction score

    Time frame: Baseline

    The patients' global satisfaction with the PBM therapy will be evaluated using a NRS from 0 (minimum score) to 10 (maximum score).

  5. Satisfaction score

    Time frame: 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).

  6. satisfaction score

    Time frame: 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 outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: 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).

  2. General patient-, disease-, and treatment-related information

    Time frame: 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).

  3. General patient-, disease-, and treatment-related information

    Time frame: 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).

  4. Cancer relapse or recurrence

    Time frame: One year post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  5. Cancer relapse or recurrence

    Time frame: Two year post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  6. Cancer relapse or recurrence

    Time frame: Three year post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  7. Cancer relapse or recurrence

    Time frame: Four year post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

  8. Cancer relapse or recurrence

    Time frame: Five year post chemotherapy

    The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Mebis, Prof. Dr.

CONTACT

[email protected]

011 33 72 21 ext. +32

Marithé Claes, MSc

CONTACT

[email protected]

011 33 72 39 ext. +32

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial

Acronym: NeuroLight 2

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Mar 10, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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