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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02133-42 | Other Identifier | ID-RCB Number |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy system CareMin650TM | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
| Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction. |
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Inclusion Criteria:
In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire VIT | Contact | (0)3 68 33 95 23 | +33 | promotion-rc@icans.eu |
| Manon VOEGELIN | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Anne ZILLIOX, MD | Institut de cancérologie Strasbourg Europe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de cancérologie Strasbourg Europe | Recruiting | Strasbourg | 67033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439757 | Background | 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. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
Consumption of systemic anti-infectives during aplasia after induction and conditioning chemotherapy. |
| 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 | Up to 12 weeks |
| Evaluate the impact of PBM in terms of reduction of the length of hospital stay. | Length of hospitalization | Up to 12 weeks |
| Evaluate the impact of PBM in terms of reduction of the number of transfusions. | Number of transfusions during hospitalization | 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. | 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 | Up to 12 weeks |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |