Leukemia, Myeloid, AcutePHOTO-TREATNCT06326268
Interest of Light Therapy in Hematology - The PHOTO-TREAT Study
A study testing Phototherapy system CareMin650TM in people with Leukemia, Myeloid, Acute and Lymphoma, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Lymphoma
- What is being tested?
- Phototherapy system CareMin650TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2024to 17 Sep 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
- Adult patient;
- Patients:
- In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
- Signature of informed consent;
- Patient registered with social security.
Who cannot join
- Patient under guardianship or curatorship
- Pregnant and breastfeeding woman
- Allergy to polyurethanes
Trial locations and contacts
1 site in 1 country.
Manon VOEGELIN contact
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
(0)3 68 33 95 23 ext. +33, promotion-rc@icans.eu
Anne ZILLIOX, MD
About this study
Official title: Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study
Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.
The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).
Read the detailed description
During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).
- Conditions
- Leukemia, Myeloid, Acute, Lymphoma
- Being tested
- Phototherapy system CareMin650TM
- Medical subject headings
- Leukemia, Myeloid, Acute, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy system CareMin650TMDevice
- As part of preventive treatment: Photobiomodulation sessions will be carried out at a dose of 3 joules for 1 minute 51 seconds, 3 times a week (for a maximum duration of 4 to 6 weeks).
- As part of curative treatment (i.e. for patients developing mucositis, from grade I): photobiomodulation will be carried out at a curative dose of 6 joules daily (for a maximum duration of 4 to 6 weeks ) for 3 minutes 34 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Other | • Patients: In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma; Receives: Device: Phototherapy system CareMin650TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria
Measured: Up to 12 weeks
Secondary outcomes (7)
Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.
Consumption of level III analgesics during aplasia after chemotherapy.
Measured: Up to 12 weeks
Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.
Consumption of systemic anti-infectives during aplasia after induction and conditioning chemotherapy.
Measured: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.
Duration of artificial nutrition during aplasia
Measured: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the length of hospital stay.
Length of hospitalization
Measured: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the number of transfusions.
Number of transfusions during hospitalization
Measured: Up to 12 weeks
Evaluate the impact of PBM in terms of pain reduction
Assessment using a visual analogue scale (VAS, graded from 0 to 10). Measurement before and after each PBM session.
Measured: Up to 12 weeks
Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay
Evaluation of patient satisfaction with the hospital stay - questions on pain management from the Picker Patient Experience Questionnaire
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start17 Apr 2024
- Primary completion17 Sep 2025 (estimated)
- Study completion17 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne ZILLIOX, MD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326268
- Sponsor's protocol ID
- 2023-019
- Other IDs
- 2023-A02133-42
- Acronym
- PHOTO-TREAT
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buclin CP, Uribe A, Daverio JE, Iseli A, Siebert JN, Haller G, Cullati S, Courvoisier DS. Validation of French versions of the 15-item picker patient experience questionnaire for adults, teenagers, and children inpatients. Front Public Health. 2024 Feb 19;12:1297769. doi: 10.3389/fpubh.2024.1297769. eCollection 2024.
PubMed 38439757
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study
- ClinicalTrials.gov ID
- NCT06326268
- Acronym / sponsor ID
- PHOTO-TREAT / 2023-019
- Conditions
- Leukemia, Myeloid, Acute, Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 Sep 2025 (estimated)
- Study completion
- 17 Sep 2025 (estimated)
- First posted
- 22 Mar 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.
Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.
The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).
Detailed description
During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Other | Device: Phototherapy system CareMin650TM• Patients: In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient;
- Patients:
- In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
- Signature of informed consent;
- Patient registered with social security.
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Pregnant and breastfeeding woman
- Allergy to polyurethanes
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 |
|---|---|---|
| Phototherapy system CareMin650TM* As part of preventive treatment: Photobiomodulation sessions will be carried out at a dose of 3 joules for 1 minute 51 seconds, 3 times a week (for a maximum duration of 4 to 6 weeks). * As part of curative treatment (i.e. for patients developing mucositis, from grade I): photobiomodulation will be carried out at a curative dose of 6 joules daily (for a maximum duration of 4 to 6 weeks ) for 3 minutes 34 seconds. | Device | Photobiomodulation |
Primary outcome
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
Time frame: Up to 12 weeks
Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria
7 secondary outcomes
Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.
Time frame: Up to 12 weeks
Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.
Time frame: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.
Time frame: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the length of hospital stay.
Time frame: Up to 12 weeks
Evaluate the impact of PBM in terms of reduction of the number of transfusions.
Time frame: Up to 12 weeks
Evaluate the impact of PBM in terms of pain reduction
Time frame: Up to 12 weeks
Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 38439757Buclin CP, Uribe A, Daverio JE, Iseli A, Siebert JN, Haller G, Cullati S, Courvoisier DS. Validation of French versions of the 15-item picker patient experience questionnaire for adults, teenagers, and children inpatients. Front Public Health. 2024 Feb 19;12:1297769. doi: 10.3389/fpubh.2024.1297769. eCollection 2024.
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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.
Manon VOEGELIN contact
Anne ZILLIOX, MD principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy system CareMin650TM in people with Leukemia, Myeloid, Acute and Lymphoma, run by Institut de cancérologie Strasbourg Europe 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 5 inclusion and 3 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 22 Apr 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 Claire VIT ((0)3 68 33 95 23 ext. +33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326268, which also lists 1 linked publication.
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 22 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.