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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Hair loss due to CT is reversible, but hair regrowth requires several months to a year after CT. Currently, the only available preventive measure is based on scalp cooling. Nevertheless, this treatment has a highly variable success rate and it brings along several side effects. Photobiomodulation therapy (PBMT) is a new, preventive and therapeutic technique in the supportive care of cancer patients. It uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (LED) at a low power to stimulate tissue repair and reduce inflammation and pain. The investigator's research team demonstrated already that PBMT can prevent oral mucositis and acute radiodermatitis. The aim of this project is to explore the use of PBMT in the management of CIA. Results of this project will lead to an improvement of the patients' quality of life after CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Treatment group | Active Comparator |
| |
| Control group (no intervention) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation therapy | Device | All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration. |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale (VAS) | A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'. | Baseline |
| visual analogue scale (VAS) | A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'. | Month 1 |
| visual analogue scale (VAS) | A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'. | Month 2 |
| visual analogue scale (VAS) | A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C30 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Baseline |
| EORTC QLQ-C30 Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeroen Mebis, prof. dr. | Contact | + 32 11 33 79 79 | jeroen.mebis@jessazh.be | |
| Joy Lodewijckx, drs. | Contact | +32 11 33 72 30 | joy.lodewijckx@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, prof. dr. | Jessa Hospital | Principal Investigator |
| Joy Lodewijckx, drs. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37060420 | Derived | Lodewijckx J, Robijns J, Claes M, Pierson M, Lenaerts M, Mebis J. The use of photobiomodulation therapy for the management of chemotherapy-induced alopecia: a randomized, controlled trial (HAIRLASER trial). Support Care Cancer. 2023 Apr 15;31(5):269. doi: 10.1007/s00520-023-07743-1. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin 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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A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module
| Month 1 |
| EORTC QLQ-C30 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Month 2 |
| EORTC QLQ-C30 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Month 3 |
| QLQ-BR23 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Baseline |
| QLQ-BR23 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Month 1 |
| QLQ-BR23 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Month 2 |
| QLQ-BR23 Quality of life questionnaire | A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module | Month 3 |
| Patient global satisfaction numerical rating scale | The patients' global satisfaction with the PBMT/sham therapy will be evaluated using a numerical rating scale (NRS) from 0 (minimum score) to 10 (maximum score) | Month 3 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |