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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Deng, University of Pennsylvania
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 37116057Deng 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
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:
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
- 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
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
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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.