Head and Neck Cancer, Lymphedema, Fibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELow-level laser
Low-level laser therapy
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized, wait-list control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years of age * \>6 months post HNC treatment * No evidence of cancer confirmed with imaging tests * Having head and neck lymphedema with or without fibrosis * Completion of initial lymphedema therapy * Lymphedema duration between 3-24 months * Ability to speak and read English * Ability to provide informed consent
Exclusion criteria
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: * Pregnancy * Acute infection * Photosensitivity * Chronic inflammatory diseases * Venous thrombosis * Carotid artery stenosis * History of severe trauma * Medication that affects body fluid and electrolyte balance * Use of high doses of non-steroidal anti-inflammatory drugs * Pre-existing skin rash, ulceration, open wound in the treatment area * Active lymphedema therapy or physical therapy * Allergic and other systemic skin diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Severity of External Lymphedema and Fibrosis (LEF) | Baseline, 8-week post-intervention visit | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Baseline, 8-week post-intervention visit | 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. |
| Neck Range of Motion Degree: Right Lateral Rotation | Baseline, 8-week post-intervention visit | 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. |
| Quality of Life Score: Feeding Tube | Baseline, 8-week post-intervention visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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. | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrew from the study before attending the study intervention sessions due to new cancer diagnosis | 1 | 0 |
| Overall Study | Withdrew from the study before attending the study intervention sessions due to unexpected job duty | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 (Laser Group) | Total | Group 2 (Wait-list Control Group) |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 5.06 | 61.0 years STANDARD_DEVIATION 5.65 | 62.3 years STANDARD_DEVIATION 6.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 25 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 22 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
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).
Time frame: Baseline, 8-week post-intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Laser Group) | Total Severity of External Lymphedema and Fibrosis (LEF) | Total severity score of LEF at baseline visit | 5.42 score on a scale | Standard Deviation 2.07 |
| Group 1 (Laser Group) | Total Severity of External Lymphedema and Fibrosis (LEF) | Total severity score of LEF at 8-week post-intervention visit | 3.22 score on a scale | Standard Deviation 1.86 |
| Group 2 (Wait-list Control Group) | Total Severity of External Lymphedema and Fibrosis (LEF) | Total severity score of LEF at baseline visit | 4.08 score on a scale | Standard Deviation 2.33 |
| Group 2 (Wait-list Control Group) | Total Severity of External Lymphedema and Fibrosis (LEF) | Total severity score of LEF at 8-week post-intervention visit | 4.62 score on a scale | Standard Deviation 1.71 |
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.
Time frame: Baseline, 8-week post-intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Laser Group) | Neck Range of Motion Degree: Right Lateral Rotation | Right lateral rotation at baseline visit | 45.38 degrees of neck movements | Standard Deviation 13.54 |
| Group 1 (Laser Group) | Neck Range of Motion Degree: Right Lateral Rotation | Right lateral rotation at 8-week post-intervention visit | 52.78 degrees of neck movements | Standard Deviation 11.18 |
| Group 2 (Wait-list Control Group) | Neck Range of Motion Degree: Right Lateral Rotation | Right lateral rotation at baseline visit | 48.04 degrees of neck movements | Standard Deviation 6.98 |
| Group 2 (Wait-list Control Group) | Neck Range of Motion Degree: Right Lateral Rotation | Right lateral rotation at 8-week post-intervention visit | 47.85 degrees of neck movements | Standard Deviation 10.92 |
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.
Time frame: Baseline, 8-week post-intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Laser Group) | Quality of Life Score: Feeding Tube | Quality of life -feeding tube scale score at baseline visit | 16.67 score on a scale | Standard Deviation 38.92 |
| Group 1 (Laser Group) | Quality of Life Score: Feeding Tube | Quality of life -feeding tube scale score at 8-week post-intervention visit | 0 score on a scale | Standard Deviation 0 |
| Group 2 (Wait-list Control Group) | Quality of Life Score: Feeding Tube | Quality of life -feeding tube scale score at baseline visit | 15.38 score on a scale | Standard Deviation 37.55 |
| Group 2 (Wait-list Control Group) | Quality of Life Score: Feeding Tube | Quality of life -feeding tube scale score at 8-week post-intervention visit | 7.69 score on a scale | Standard Deviation 27.74 |
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.
Time frame: Baseline, 8-week post-intervention visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Laser Group) | Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Soft Tissues and Neurologic Toxicity at baseline | 2.46 score on a scale | Standard Deviation 0.97 |
| Group 1 (Laser Group) | Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Soft Tissues and Neurologic Toxicity at 8-week post-intervention visit | 1.73 score on a scale | Standard Deviation 1.32 |
| Group 2 (Wait-list Control Group) | Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Soft Tissues and Neurologic Toxicity at baseline | 1.63 score on a scale | Standard Deviation 1.03 |
| Group 2 (Wait-list Control Group) | Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale | Soft Tissues and Neurologic Toxicity at 8-week post-intervention visit | 1.23 score on a scale | Standard Deviation 0.92 |