Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Cancer of the Gastrointestinal Tract Clinical Trial

Official title:

Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199115
• Other study ID #: Neurosudoscan
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Saint-Gregoire Private Hospital Center
• Contact: Morgane Pihan, MD
• Phone: +33 2 93 23 97 80
• Email: mpihan[@]vivalto-sante.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Gastrointestinal Tract
• Gastrointestinal Neoplasms
• Neuralgia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHP Saint-Grégoire	Saint-Grégoire

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Gregoire Private Hospital Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic Pain Synptom Inventory : pain	Is is a score with 12 items. 10 items concern pain and are scale from 0 (no pain) to 10 (maximal pain).	day 30, day 60, day 90, day 120, day 150, day 180, day 270
Secondary	Health-relative quality of life of cancer patients participating to a clinical trial	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.	day 0, day 60, day 120, day 180, day 270
Secondary	Peripheral neuropathy : SUDOSCAN evaluation	Evaluation of peripheral neuropathy by SUDOSCAN (detection and evaluation of small fiber neuropathies)	day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270
Secondary	Peripheral neuropathy : electroneuromyogram evaluation	Evaluation by electroneuromyogram : measurement of nerve conduction velocity	day 0, day 90, day 270
Secondary	Evaluation of sensitive and motor symptoms	TNSc score : 7 items to explore sensitive and motor symptoms, scored from 0 (no symptom) from 4 (very important symptoms)	day 30, day 60, day 90, day 120, day 150, day 180, day 270