Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Not Applicable

Recruiting

• Conditions: Cancer of the Gastrointestinal Tract
• Interventions: Procedure: Photobiomodulation

• Registration Number: NCT06199115
• Lead Sponsor: Saint-Gregoire Private Hospital Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Photobiomodulation	Patients will receive three photobiomodulation sessions per week during their oxaliplatin chemotherapy cycles

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain Synptom Inventory : pain	day 30, day 60, day 90, day 120, day 150, day 180, day 270	Is is a score with 12 items. 10 items concern pain and are scale from 0 (no pain) to 10 (maximal pain).

Secondary Outcome Measures

Name	Time	Method
Peripheral neuropathy : electroneuromyogram evaluation	day 0, day 90, day 270	Evaluation by electroneuromyogram : measurement of nerve conduction velocity
Health-relative quality of life of cancer patients participating to a clinical trial	day 0, day 60, day 120, day 180, day 270	QLQ-C30 EORTC scale : 30 items scored from 1 (not at all) to 4 (very). Global health status, functional scales and symptom scales are reported.
Peripheral neuropathy : SUDOSCAN evaluation	day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270	Evaluation of peripheral neuropathy by SUDOSCAN (detection and evaluation of small fiber neuropathies)
Evaluation of sensitive and motor symptoms	day 30, day 60, day 90, day 120, day 150, day 180, day 270	TNSc score : 7 items to explore sensitive and motor symptoms, scored from 0 (no symptom) from 4 (very important symptoms)

Trial Locations

Locations (1)

CHP Saint-Grégoire; 🇫🇷 Saint-Grégoire, France