Head and Neck CancerNCT03738332

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

A study testing Low-Level Laser in people with Head and Neck Cancer and Lymphedema, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Cancer, Lymphedema, Fibrosis
What is being tested?: Low-Level Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 25 Feb 2019to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

>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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions: Head and Neck Cancer, Lymphedema, Fibrosis
Being tested: Low-Level Laser
Medical subject headings: Head and Neck Neoplasms, Lymphedema, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-Level LaserDevice
Low-level laser therapy

Study groups in NCT03738332
Study group	Role	What they receive
Low-level laser therapy	Other	Single arm Receives: Device: Low-Level Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Consented and Enrolled in Study
Number of participants who consented the study and number of participants who enrolled in the study
Measured: Approximately 5-month recruitment window
Number of Participants Completed the Study Visits
Number of participants who completed the study visits
Measured: 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.
Measured: 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).
Measured: at 4-week post-intervention visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 201931 Dec 2020

First posted13 Nov 2018
Study start25 Feb 2019
Primary completion31 Dec 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Head and Neck CancerStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Pre-and post design
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03738332
Sponsor's protocol ID: UPCC12318
Status last verified: Jan 2022
First submitted: 8 Nov 2018
Last updated: 1 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 37116057
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.
PubMed 34387119

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Head and Neck Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
ClinicalTrials.gov ID: NCT03738332
Acronym / sponsor ID: UPCC12318
Conditions: Head and Neck Cancer, Lymphedema, Fibrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 25 Feb 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 13 Nov 2018 (actual)
Results: Posted 25 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Pre-and post design

Arm	Type	Receives
Low-level laser therapy	Other	Device: Low-Level LaserSingle arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

>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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low-Level LaserLow-level laser therapy	Device	Low-level laser therapy

Primary outcome

Number of Participants Consented and Enrolled in Study
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-level Laser Therapy	12	11

Primary outcome: Number of Participants Consented and Enrolled in Study

Time frame: Approximately 5-month recruitment window. Count of participants. Unit: Participants

Measure	Low-level Laser Therapy n = 30
Value	12

Primary outcome: Number of Participants Completed the Study Visits

Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit. Count of participants. Unit: Participants

Measure	Low-level Laser Therapy n = 12
Value	11

Primary outcome: Number of Participants With Adverse Events

Time frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit. Count of participants. Unit: Participants

Measure	Low-level Laser Therapy n = 12
Value	0

Primary outcome: Number of Participants Who Were Satisfied With Study Intervention.

Time frame: at 4-week post-intervention visit. Count of participants. Unit: Participants

Measure	Low-level Laser Therapy n = 11
Value	11

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. .. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-level Laser Therapy	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37116057Deng 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.
Derived from this study: PubMed 34387119Deng 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.
Individual participant dataSharing planned: Undecided

Related trials for Head and Neck Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low-Level Laser in people with Head and Neck Cancer and Lymphedema, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Consented and Enrolled in Study (time frame: Approximately 5-month recruitment window). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738332, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.