Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Saint-Gregoire Private Hospital Center

Status: Enrolling

Conditions: Cancer of the Gastrointestinal Tract

Treatments: Procedure: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06199115

Neurosudoscan

Details and patient eligibility

About

Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recent diagnosis of digestive cancer
• 12 planned cycles of oxaliplatin
• Ability to understand and willingness to sign an informed consent form before starting any study procedures
• Patient benefiting from French health insurance

Exclusion criteria

• History of neuropathy before the start of the study,
• Symptomatic treatment of pain (or neuropathic pain),
• Patient with a psychotic disorder,
• Patient with diabetic neuropathy,
• Patient with metastatic cancer
• Patient with renal insufficiency,
• Adults under guardianship or curatorship,
• Vulnerable people

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control

No Intervention group

Description:

Patients will not receive any intervention during their oxaliplatin chemotherapy cycles.

Experimental

Experimental group

Description:

Patients will receive three photobiomodulation sessions per week during their oxaliplatin chemotherapy cycles

Treatment:

Procedure: Photobiomodulation