Photobiomodulation Therapy for Head and Neck Cancers

Recruiting at 1 trial location

Overseen By Sarah Latimore, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Diuretics, Corticosteroids

Disqualifiers: Chronic inflammatory diseases, Venous thrombosis, Carotid artery stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who need to keep using diuretics and corticosteroids. It might be best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment LTU-904 Portable Laser Therapy Unit for head and neck cancers?

Research shows that low-level laser therapy, also known as photobiomodulation, is effective in reducing oral mucositis (painful mouth sores) in patients undergoing treatment for head and neck cancer. This therapy can help improve the quality of life for these patients by managing side effects of cancer treatment. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

There is a large body of evidence supporting the safety of photobiomodulation therapy (also known as low-level laser therapy) for managing side effects like oral mucositis in patients undergoing treatment for head and neck cancer. ^{1 2 3 4 5}

How is photobiomodulation therapy different from other treatments for head and neck cancers?

Photobiomodulation therapy (also known as low-level laser therapy) is unique because it uses light to help heal and reduce symptoms like oral mucositis (painful mouth sores) caused by cancer treatments. Unlike traditional treatments, it is non-invasive and focuses on reducing side effects rather than directly targeting cancer cells. ^{1 2 5 6 7}

Eligibility Criteria

This trial is for individuals who have survived head and neck cancer but are experiencing chronic lymphedema, a condition where excess fluid collects in tissues causing swelling. The study seeks participants to confirm the effectiveness of a therapy called PBMT.

Inclusion Criteria

Patients must be able to understand English in order to complete questionnaires and provide informed consent

My head or neck cancer has been confirmed by a biopsy.

I am older than 18 years.

Exclusion Criteria

I do not have conditions like pregnancy, infections, or skin issues that would make PBMT unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PBMT or sham therapy twice a week for 6 weeks, followed by once a week for 6 weeks

12 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3-, 6-, 9-, and 12-month post-intervention visits

Treatment Details

Interventions

• LTU-904 Portable Laser Therapy Unit

Trial Overview The trial is testing the effects of Photobiomodulation Therapy (PBMT) using an LTU-904 Portable Laser Therapy Unit. Participants will be randomly assigned to receive either active laser treatment or a sham (inactive) device as part of the study.

Participant Groups

Group I: ARM A: PBMT12 Active Control 2 Interventions

After completion of the baseline measures, participants in ARM A will be scheduled for PBMT twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sessions: 12 PBMT and 6 sham therapy sessions).

Group II: ARM B: PBMT18 Active Control 1 Intervention

After completion of the baseline measures, participants in ARM B will be scheduled for PBMT twice a week for 6 weeks followed by PBMT once per week for 6 weeks (a total of 18 PBMT sessions).

Group III: ARM C: Placebo Placebo Group 1 Intervention

After completion of the baseline measures, participants in ARM C will receive sham therapy, twice a week for 6 weeks followed by sham therapy once per week for 6 weeks (a total of 18 sham therapy sessions).

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Low-level laser therapy (LLLT), also known as PhotoBioModulation (PBM), has strong evidence supporting its effectiveness in preventing and treating oral mucositis in patients undergoing radiotherapy for head and neck cancer or high-dose chemotherapy.

Recent advancements in LLLT/PBM technology and understanding of its mechanisms may allow it to manage a wider range of cancer treatment side effects, potentially improving patient adherence to therapy and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. Bensadoun, RJ.[2019]

In a study involving 73 cancer patients undergoing radiotherapy, the Photobiomodulation protocol in Group 1 (660 nm, 15 mW, 3.8 J/cm2) was found to significantly delay the onset of grade II oral mucositis compared to the other protocols, indicating its superior efficacy.

Patients in Group 1 also reported lower pain scores related to oral mucositis, suggesting that this Photobiomodulation protocol not only reduces the severity of mucositis but also alleviates associated pain more effectively than the other treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. de Carvalho, PAG., Lessa, RC., Carraro, DM., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Low level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 1: mechanisms of action, dosimetric, and safety considerations. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of preventive laser photobiomodulation in patients with head and neck cancer undergoing radiochemotherapy: Laser in patients with head and neck cancer. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy: management of mucosal necrosis of the oropharynx in previously treated head and neck cancer patients. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. [2021]