Cancer of the Gastrointestinal Tract
Conditions
Keywords
Photobiomodulation, Pain, oxaliplatin, peripheral neuropathy, chemotherapy, SUDOSCAN
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.
Interventions
PROCEDUREPhotobiomodulation
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.
Sponsors
Saint-Gregoire Private Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Peripheral neuropathy : electroneuromyogram evaluation | day 0, day 90, day 270 | Evaluation by electroneuromyogram : measurement of nerve conduction velocity |
| 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) |
Countries
France
Contacts
Primary ContactMorgane Pihan, MD
Outcome results
None listed