Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

NCT06199115 | Unknown

• 1 other identifier: Neurosudoscan
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the Gastrointestinal Tract

Keywords

Photobiomodulation; Pain; oxaliplatin; peripheral neuropathy; chemotherapy; SUDOSCAN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health-relative quality of life of cancer patients participating to a clinical trial

  day 0, day 60, day 120, day 180, day 270

• Peripheral neuropathy : SUDOSCAN evaluation

  day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270

• Peripheral neuropathy : electroneuromyogram evaluation

  day 0, day 90, day 270

• Evaluation of sensitive and motor symptoms

  day 30, day 60, day 90, day 120, day 150, day 180, day 270

Study Arms (2)

Control

NO INTERVENTION

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

Experimental

EXPERIMENTAL

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

Procedure: Photobiomodulation

Interventions

Photobiomodulation 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent diagnosis of digestive cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Gregoire Private Hospital Center: lead

Study Sites (1)

CHP Saint-Grégoire

Saint-Grégoire, 35700, France

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Pain; Peripheral Nervous System Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Morgane Pihan

  CHP Saint-Grégoire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgane Pihan, MD

CONTACT

+33 2 93 23 97 80; mpihan@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 10, 2024
• Study Start: May 31, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)