Clinical trial NCT05763706: Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy
Official title: Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Photobiomodulation therapy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data).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

Eligibility criteria: 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)

Primary outcomes:
measure: Modified total neuropathy score (mTNS)
timeFrame: Baseline
measure: Modified total neuropathy score (mTNS)
timeFrame: End of PBM (six weeks post-baseline)
measure: Modified total neuropathy score (mTNS)
timeFrame: Three weeks post-PBM
measure: Pain score
timeFrame: Baseline
measure: Pain score
timeFrame: End of PBM (six weeks post-baseline)
measure: Pain score
timeFrame: Three weeks post-PBM
measure: Mobility score
timeFrame: Baseline
measure: Mobility score
timeFrame: End of PBM (six weeks post-baseline)
measure: Mobility score
timeFrame: Three weeks post-PBM
Secondary outcomes:
measure: Quality of life score
timeFrame: Baseline
measure: Quality of life score
timeFrame: End of PBM (six weeks post-baseline)
measure: Quality of life score
timeFrame: Three weeks post-PBM
measure: Satisfaction score
timeFrame: Baseline
measure: Satisfaction score
timeFrame: End of PBM (six weeks post-baseline)
measure: satisfaction score
timeFrame: Three weeks post-PBM
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: End of PBM (six weeks post-baseline)
measure: General patient-, disease-, and treatment-related information
timeFrame: Three weeks post-PBM
measure: Cancer relapse or recurrence
timeFrame: One year post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Two year post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Three year post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Four year post chemotherapy
measure: Cancer relapse or recurrence
timeFrame: Five year post chemotherapy
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Jeroen mebis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: