Head and Neck CancerNCT04482855
Low-Level Laser in Head and Neck Chronic Lymphedema
A study testing Low-level laser in people with Head and Neck Cancer and Lymphedema, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 30 Jun 2023
- 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
- >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
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
- Acute infection
- Photosensitivity
- Chronic inflammatory diseases
- Venous thrombosis
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
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.
Read the 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.
- 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 |
|---|---|---|
| Group 1 (laser group) | Experimental | 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. Receives: Device: Low-level laser |
| Group 2 (wait-list control group) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 8-week post-intervention visit
Secondary outcomes (3)
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.
Measured: Baseline, 8-week post-intervention visit
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.
Measured: Baseline, 8-week post-intervention visit
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.
Measured: Baseline, 8-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 posted23 Jul 2020
- Study start19 Aug 2021
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
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 (1)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 Abramson Cancer Center at Penn MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, wait-list control
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Deng, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482855
- Sponsor's protocol ID
- UPCC 01320
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2020
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Deng J, Lukens JN, Murphy BA, McMenamin E, Rajasekaran K, Quinn RJ, Cohn JC, Schlessinger W, Andersen LP, Spinelli BA, Lin A. Photobiomodulation in Treatment of Head and Neck Cancer-Related Chronic Lymphedema: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439138. doi: 10.1177/15347354261439138. Epub 2026 May 3.
PubMed 42071320
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04482855
- Acronym / sponsor ID
- UPCC 01320
- Conditions
- Head and Neck Cancer, Lymphedema, Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 19 Nov 2024
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, wait-list control
| Arm | Type | Receives |
|---|---|---|
| Group 1 (laser group) | Experimental | Device: Low-level laserGroup 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. |
| Group 2 (wait-list control group) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >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
Key exclusion criteria (13 listed)
- 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
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 | Group 1 (laser group) |
Primary outcome
Total Severity of External Lymphedema and Fibrosis (LEF)
Time frame: 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).
3 secondary outcomes
Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale
Time frame: Baseline, 8-week post-intervention visit
Neck Range of Motion Degree: Right Lateral Rotation
Time frame: Baseline, 8-week post-intervention visit
Quality of Life Score: Feeding Tube
Time frame: Baseline, 8-week post-intervention visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42071320Deng J, Lukens JN, Murphy BA, McMenamin E, Rajasekaran K, Quinn RJ, Cohn JC, Schlessinger W, Andersen LP, Spinelli BA, Lin A. Photobiomodulation in Treatment of Head and Neck Cancer-Related Chronic Lymphedema: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439138. doi: 10.1177/15347354261439138. Epub 2026 May 3.
- 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 Abramson Cancer Center at Penn Medicine 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 8 inclusion and 13 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 19 Nov 2024. 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 19 Nov 2024). 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?
Total Severity of External Lymphedema and Fibrosis (LEF) (time frame: Baseline, 8-week post-intervention visit). 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 NCT04482855, which also lists 1 linked publication.
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 19 Nov 2024.