Cancer of the Gastrointestinal TractNCT06199115
Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation
A study testing Photobiomodulation in people with Cancer of the Gastrointestinal Tract, run by Saint-Gregoire Private Hospital Center at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Gastrointestinal Tract
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHP Saint-Grégoire
Saint-Grégoire, 35700
Morgane Pihan, MD, +33 2 93 23 97 80, mpihan@vivalto-sante.com
About this study
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
- Being tested
- Photobiomodulation
- Keywords
- Photobiomodulation, Pain, oxaliplatin, peripheral neuropathy, chemotherapy, SUDOSCAN
- Medical subject headings
- Gastrointestinal Neoplasms, Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: day 0, day 60, day 120, day 180, day 270
Peripheral neuropathy : SUDOSCAN evaluation
Evaluation of peripheral neuropathy by SUDOSCAN (detection and evaluation of small fiber neuropathies)
Measured: 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
Measured: 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)
Measured: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start31 May 2023
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Gastrointestinal TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Gregoire Private Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgane Pihan, Principal investigator, CHP Saint-Grégoire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199115
- Sponsor's protocol ID
- Neurosudoscan
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation
- ClinicalTrials.gov ID
- NCT06199115
- Acronym / sponsor ID
- Neurosudoscan
- Conditions
- Cancer of the Gastrointestinal Tract
- Keywords
- Photobiomodulation, Pain, oxaliplatin, peripheral neuropathy, chemotherapy, SUDOSCAN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saint-Gregoire Private Hospital CenterUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will not receive any intervention during their oxaliplatin chemotherapy cycles. |
| Experimental | Experimental | Procedure: PhotobiomodulationPatients will receive three photobiomodulation sessions per week during their oxaliplatin chemotherapy cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationIn 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. | Procedure or surgery | Experimental |
Primary outcome
Neuropathic Pain Synptom Inventory : pain
Time frame: 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).
4 secondary outcomes
Health-relative quality of life of cancer patients participating to a clinical trial
Time frame: day 0, day 60, day 120, day 180, day 270
Peripheral neuropathy : SUDOSCAN evaluation
Time frame: day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270
Peripheral neuropathy : electroneuromyogram evaluation
Time frame: day 0, day 90, day 270
Evaluation of sensitive and motor symptoms
Time frame: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgane Pihan principal investigator
CHP Saint-Grégoire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Cancer of the Gastrointestinal Tract, run by Saint-Gregoire Private Hospital Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morgane Pihan, MD (+33 2 93 23 97 80, mpihan@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Synptom Inventory : pain (time frame: day 30, day 60, day 90, day 120, day 150, day 180, day 270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.