Head and Neck Cancer, Lymphedema, Fibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELow-Level Laser
Low-level laser therapy
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pre-and post design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years of age * Completion of either postoperative radiation or chemoradiation therapy * No evidence of cancer * Having head and neck external lymphedema * Either completion of lymphedema therapy or not in active lymphedema therapy * Ability to speak and read English * Able 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; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Consented and Enrolled in Study | Approximately 5-month recruitment window | Number of participants who consented the study and number of participants who enrolled in the study |
| Number of Participants Completed the Study Visits | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit | Number of participants who completed the study visits |
| Number of Participants With Adverse Events | Approximately 10 weeks, from baseline visit to 4-week post-intervention visit | Number of participants who experienced adverse events during the course of the study. |
| Number of Participants Who Were Satisfied With Study Intervention. | at 4-week post-intervention visit | Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-level Laser Therapy Single arm
Low-Level Laser: Low-level laser therapy | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Low-level Laser Therapy |
|---|---|
| Age, Continuous | 58.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants Completed the Study Visits
Number of participants who completed the study visits
Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-level Laser Therapy | Number of Participants Completed the Study Visits | 11 Participants |
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
Time frame: Approximately 5-month recruitment window
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-level Laser Therapy | Number of Participants Consented and Enrolled in Study | 12 Participants |
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).
Time frame: at 4-week post-intervention visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-level Laser Therapy | Number of Participants Who Were Satisfied With Study Intervention. | 11 Participants |
Primary
Number of Participants With Adverse Events
Number of participants who experienced adverse events during the course of the study.
Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-level Laser Therapy | Number of Participants With Adverse Events | 0 Participants |