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The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.
Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (laser group) | Experimental | Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection. |
|
| Group 2 (wait-list control group) | No Intervention | Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-level laser | Device | Low-level laser therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Severity of External Lymphedema and Fibrosis (LEF) | Head and Neck Lymphedema and Fibrosis Assessment Criteria Change in total severity of external LEF from baseline to 8-week post-intervention visits. A larger change in this score means more reduction in the severity of external LEF. External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3). | Baseline, 8-week post-intervention visit |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Head and Neck Lymphedema and Fibrosis Symptom Inventory Change in symptom burden score from baseline to 8-week post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (Soft Tissues and Neurologic Toxicity) score is reported here. |
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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:
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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 |
|---|---|---|---|
| 42071320 | Derived | Deng J, Lukens JN, Murphy BA, McMenamin E, Rajasekaran K, Quinn RJ, Cohn JC, Schlessinger W, Andersen LP, Spinelli BA, Lin A. Photobiomodulation in Treatment of Head and Neck Cancer-Related Chronic Lymphedema: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439138. doi: 10.1177/15347354261439138. Epub 2026 May 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Laser Group) | Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection. Low-level laser: Low-level laser therapy |
| FG001 | Group 2 (Wait-list Control Group) | Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Laser Group) | Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection. Low-level laser: Low-level laser therapy |
| BG001 |
| 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 | Total Severity of External Lymphedema and Fibrosis (LEF) | Head and Neck Lymphedema and Fibrosis Assessment Criteria Change in total severity of external LEF from baseline to 8-week post-intervention visits. A larger change in this score means more reduction in the severity of external LEF. External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-week post-intervention visit |
|
Adverse event data were collected from the baseline visit to 8-week post-intervention visit.
Common Terminology Criteria for Advance Events (CTCAE) version 5.0 was used to evaluate adverse events of the trial.
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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 | Group 1 (Laser Group) | Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection. Low-level laser: Low-level laser therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jie Deng | University of Pennsylvania School of Nursing | 2155734729 | 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 | Sep 12, 2022 | Jul 18, 2024 | Prot_SAP_000.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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Randomized, wait-list control
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| Baseline, 8-week post-intervention visit |
| Neck Range of Motion Degree: Right Lateral Rotation | Change in neck range of motion degree from baseline to 8-week post-intervention. A larger change in this degree means better outcome with increased neck range of motion. Cervical Range of Motion Device, a valid and reliable tool, was used to measure the amount of neck movement (degrees) for the following neck movements: forward flexion, extension, right and left lateral flexion, and right and left rotation. Only right lateral rotation is reported here. | Baseline, 8-week post-intervention visit |
| Quality of Life Score: Feeding Tube | EORTC QLQ-H&N35 was used to assess HNC-related quality of life. Change in EORTC QLQ-H&N35 score from baseline to 8-week post-intervention. A larger reduction in this score means decreased symptom burden and better quality of life. The HNC-specific EORTC QLQ-H&N35 module is a supplement, containing seven multi-item scales (pain, swallowing, senses problems, speech problems, trouble with social eating and social contact, and less sexuality) and eleven single-item scales (teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain). The QLQ-H&N35 scale employs a 4-point response format (''not at all" to ''very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the symptoms scales, a higher score indicates a higher level of symptom burden. Only feeding tube scale is reported here. | Baseline, 8-week post-intervention visit |
| Withdrew from the study before attending the study intervention sessions due to new cancer diagnosis |
|
| Group 2 (Wait-list Control Group) |
Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2 (Wait-list Control Group) | Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. |
|
|
| Secondary | Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Head and Neck Lymphedema and Fibrosis Symptom Inventory Change in symptom burden score from baseline to 8-week post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (Soft Tissues and Neurologic Toxicity) score is reported here. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-week post-intervention visit |
|
|
|
| Secondary | Neck Range of Motion Degree: Right Lateral Rotation | Change in neck range of motion degree from baseline to 8-week post-intervention. A larger change in this degree means better outcome with increased neck range of motion. Cervical Range of Motion Device, a valid and reliable tool, was used to measure the amount of neck movement (degrees) for the following neck movements: forward flexion, extension, right and left lateral flexion, and right and left rotation. Only right lateral rotation is reported here. | Posted | Mean | Standard Deviation | degrees of neck movements | Baseline, 8-week post-intervention visit |
|
|
|
| Secondary | Quality of Life Score: Feeding Tube | EORTC QLQ-H&N35 was used to assess HNC-related quality of life. Change in EORTC QLQ-H&N35 score from baseline to 8-week post-intervention. A larger reduction in this score means decreased symptom burden and better quality of life. The HNC-specific EORTC QLQ-H&N35 module is a supplement, containing seven multi-item scales (pain, swallowing, senses problems, speech problems, trouble with social eating and social contact, and less sexuality) and eleven single-item scales (teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain). The QLQ-H&N35 scale employs a 4-point response format (''not at all" to ''very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the symptoms scales, a higher score indicates a higher level of symptom burden. Only feeding tube scale is reported here. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-week post-intervention visit |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Group 2 (Wait-list Control Group) | Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |