Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer of the Gastrointestinal Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

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

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type PROCEDURE

In oncology, photobiomodulation is used to help heal damaged tissues, improve immune response, reduce inflammation, and prevent or treat certain side effects of treatments such as chemotherapy. Photobiomodulation is also the subject of recent clinical studies to expand its indications (peripheral neuropathies induced by certain chemotherapies.

Patients in the experimental group will receive 3 photobiomodulation sessions per week during their oxaliplatin treatments (6 months), for a total of 72 sessions. Exposition to laser light is 30 minutes for each session.

Interventions

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Photobiomodulation

In oncology, photobiomodulation is used to help heal damaged tissues, improve immune response, reduce inflammation, and prevent or treat certain side effects of treatments such as chemotherapy. Photobiomodulation is also the subject of recent clinical studies to expand its indications (peripheral neuropathies induced by certain chemotherapies.

Patients in the experimental group will receive 3 photobiomodulation sessions per week during their oxaliplatin treatments (6 months), for a total of 72 sessions. Exposition to laser light is 30 minutes for each session.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No