NCT Number: NCT06623305
The goal of this clinical trial is to learn if light therapy can prevent mouth sores in children with cancer. The main questions it aims to answer are:
Is it reasonable and acceptable to provide light therapy for children with cancer?
Does light therapy prevent mouth sores related to medical treatment?
Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis.
Participants will:
* Complete a survey. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
Trial opening soon.
Get NotifiedUp to 30 year
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Amberley Kemic, BSN
SUB_INVESTIGATOR
Amy Pan, PhD
SUB_INVESTIGATOR
Ashley Hain, BSN
SUB_INVESTIGATOR
Elissa Shulta, DNP
CONTACT
Elissa Shulta, DNP
PRINCIPAL_INVESTIGATOR
Meredith Beversdorf, BSN
SUB_INVESTIGATOR
Peter Shaw, MD
CONTACT
Peter Shaw, MD
SUB_INVESTIGATOR
Sarah Joost, MSN
SUB_INVESTIGATOR
Valerie Lohse, MSN
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients <7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes.
Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Other names: PBM, Light therapy
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients <7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes.
Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Other names: PBM, Light therapy
Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible.
Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy.
Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record based on the number of unique patients with the value of "mucositis/stomatitis" in the oral mucosa flowsheet row. Additionally, mucositis onset, severity, and grade will be measured using the CTCAE grading scale and the ChIMES patient/caregiver survey
Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the rate of MBI CLABSIs per 1,000 line days.
Contact information is provided by the study sponsor or research team.
Elissa Shulta, DNP
CONTACT
Peter Shaw, MD
CONTACT
Medical College of Wisconsin
Other
Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
Acronym: PBM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04187222
Digestive System Diseases, Gastroenteritis
Ribeirão Preto, São Paulo, Brazil
View Trial DetailsNCT07653360
Mouth Diseases, Mucositis Oral
San Francisco, California, United States
View Trial DetailsNCT07183267
Digestive System Diseases, Esophageal Diseases
Manchester, Cheshire, United Kingdom
View Trial DetailsNCT06031012
Mouth Diseases, Mucositis Oral
Xi'an, Shaanxi, China
View Trial Details