Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute

About this trial

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. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. 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. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.

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)

Be able to understand the ICF and study-related questionnaires

Disqualifiers

severe or unstable cardio-respiratory or musculoskeletal disease

Peripheral neuropathy previous to chemotherapy

Receiving potentially neurotoxic therapies other than given for cancer treatment

Interruption of more than two consecutive laser treatments

Trial design

Design model

Crossover

Treatments tested in this trial

  • Photobiomodulation

    Device

    Patients will receive 20 Joule/cm2

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: PBM groupExperimental treatment 1 intervention
Group B: Sham-PBM groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

severity of CIPN measured by modified Total Neurpathy Score m-TNS

Include several simple neurological tests

Time frame
At baseline (week 0) and at week 3 and week 6

Secondary outcomes

1

Pain & satisfaction by Numeric Rating Scale (0-10)

Pain \& satisfaction by Numeric Rating Scale (0-10)

Time frame
At baseline (Week0), and Week 3 and Week 6
2

Mobility by 6min walking test

Mobility by 6min walking test and

Time frame
At baseline (Week0), and Week 3 and Week 6
3

Quality of life by FACT-GOG-NTX questionnair

Quality of life by FACT-GOG-NTX questionnaire

Time frame
At baseline (Week0), and Week 3 and Week 6

Other outcomes

Sponsors and contacts

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