Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03738332
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Lymphedema; Fibrosis	Device: Low-Level Laser	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pre-and post designPre-and post design
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
• Actual Study Start Date: Feb 25, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Low-level laser therapy Single arm	Device: Low-Level Laser; Low-level laser therapy

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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.

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2019

More Information

Publications

None provided.

• Responsible Party: Jie Deng, Associate Professor, PhD, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03738332
• Other Study ID Numbers: UPCC12318
• First Posted: Nov 13, 2018
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Lymphedema

Study Results

Participant Flow

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy
Overall Participants	12
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	58.4
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	10 83.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 8.3%
White	11 91.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Consented and Enrolled in Study
Description	Number of participants who consented the study and number of participants who enrolled in the study
Time Frame	Approximately 5-month recruitment window

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy
Measure Participants	30
Count of Participants [Participants]	12 100%

2. Primary Outcome

Title	Number of Participants Completed the Study Visits
Description	Number of participants who completed the study visits
Time Frame	Approximately 10 weeks, from baseline visit to 4-week post-intervention visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy
Measure Participants	12
Count of Participants [Participants]	11 91.7%

3. Primary Outcome

Title	Number of Participants With Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy
Measure Participants	12
Count of Participants [Participants]	0 0%

4. Primary Outcome

Title	Number of Participants Who Were Satisfied With Study Intervention.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy Dose: twice a week for 6 weeks (12 sessions)
Measure Participants	11
Count of Participants [Participants]	11 91.7%

Adverse Events

Time Frame	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. .
Arm/Group Title	Low-level Laser Therapy
Arm/Group Description	Single arm Low-Level Laser: Low-level laser therapy
All Cause Mortality
	Low-level Laser Therapy
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Low-level Laser Therapy
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Low-level Laser Therapy
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.