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The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.
Primary aim:
To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-level laser therapy | Other | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Level Laser | Device | Low-level laser therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Consented and Enrolled in Study | Number of participants who consented the study and number of participants who enrolled in the study | Approximately 5-month recruitment window |
| Number of Participants Completed the Study Visits | Number of participants who completed the study visits | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit |
| Number of Participants With Adverse Events | Number of participants who experienced adverse events during the course of the study. | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit |
| Number of Participants Who Were Satisfied With Study Intervention. | Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy). | at 4-week post-intervention visit |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37116057 | Derived | Deng J, Lukens JN, Zhu J, Cohn JC, Andersen LP, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Patient Experience of Photobiomodulation Therapy in Head and Neck Chronic Lymphedema. J Palliat Med. 2023 Sep;26(9):1225-1233. doi: 10.1089/jpm.2021.0419. Epub 2023 Apr 28. | |
| 34387119 | Derived | Deng J, Lukens JN, Swisher-McClure S, Cohn JC, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211037938. doi: 10.1177/15347354211037938. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-level Laser Therapy | Single arm Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-level Laser Therapy | Single arm Low-Level Laser: Low-level laser therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Consented and Enrolled in Study | Number of participants who consented the study and number of participants who enrolled in the study | Posted | Count of Participants | Participants | Approximately 5-month recruitment window |
|
|
The adverse events were monitored and assessed during the course of the study, that is, from the start of the intervention up to 4 weeks post intervention, up to approximately 10 weeks. .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-level Laser Therapy | Single arm Low-Level Laser: Low-level laser therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jie Deng | University of Pennsylvania | 215-573-2393 | jiedeng@nursing.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2019 | Dec 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008209 | Lymphedema |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic 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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Pre-and post design
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants Completed the Study Visits | Number of participants who completed the study visits | Posted | Count of Participants | Participants | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit |
|
|
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| Primary | Number of Participants With Adverse Events | Number of participants who experienced adverse events during the course of the study. | Posted | Count of Participants | Participants | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit |
|
|
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| Primary | Number of Participants Who Were Satisfied With Study Intervention. | Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy). | Posted | Count of Participants | Participants | at 4-week post-intervention visit |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |