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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Peripheral neuropathy : SUDOSCAN evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morgane Pihan, MD | Contact | +33 2 93 23 97 80 | mpihan@vivalto-sante.com |
| Name | Affiliation | Role |
|---|---|---|
| Morgane Pihan | CHP Saint-Grégoire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHP Saint-Grégoire | Recruiting | Saint-Grégoire | 35700 | France |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
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 |
| Peripheral neuropathy : electroneuromyogram evaluation | Evaluation by electroneuromyogram : measurement of nerve conduction velocity | day 0, day 90, day 270 |
| 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 |
| D005767 |
| Gastrointestinal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |