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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of photobiomodulation therapy (PBMT) for individuals with chronic lymphedema related to head and neck cancer. The trial aims to confirm PBMT's ability to reduce swelling, building on earlier studies that showed promising results. Participants will receive either actual PBMT using the LTU-904 Portable Laser Therapy Unit or a placebo treatment. The trial seeks individuals who have had head and neck cancer, experienced persistent swelling for at least six months, and have not found success with other treatments. As an unphased trial, it offers a unique opportunity to explore a promising treatment option for those who have not found relief with existing therapies.

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 prior data suggests that photobiomodulation therapy is safe for head and neck cancer-related lymphedema?

Research has shown that photobiomodulation therapy (PBMT) using the LTU-904 Portable Laser Therapy Unit is safe for people. Studies have found that this therapy is generally well-tolerated. The LTU-904 is a Class I laser, which means it doesn't pose a risk of eye damage, so safety glasses are not required during use. Unlike other laser therapies, this laser doesn't produce heat, alleviating a common concern. Additionally, the FDA has approved this treatment for reducing swelling in breast cancer patients, indicating a strong safety record. While specific side effects aren't listed, FDA approval suggests that any potential side effects are minimal or manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photobiomodulation therapy (PBMT) is unique because it uses low-level laser light to stimulate healing and reduce inflammation in head and neck cancers. Unlike traditional treatments such as surgery, radiation, or chemotherapy that can have significant side effects, PBMT is non-invasive and aims to minimize discomfort while promoting tissue repair. Researchers are excited about PBMT because it offers a potential new way to enhance recovery and quality of life for cancer patients without the harsh side effects associated with standard treatments.

What evidence suggests that photobiomodulation therapy might be an effective treatment for head and neck cancer-related chronic lymphedema?

Research has shown that photobiomodulation therapy (PBMT) may help treat chronic lymphedema, which is swelling, in individuals who have survived head and neck cancer. Previous patients found PBMT both practical and effective for this condition. This trial will evaluate PBMT using the LTU-904 Portable Laser Therapy Unit. Participants will be assigned to different arms, with some receiving PBMT sessions and others receiving sham therapy. This treatment uses low-level laser therapy to reduce swelling and improve lymph fluid flow. While the FDA has approved the therapy for arm swelling related to breast cancer, early studies suggest it may also help with swelling related to head and neck cancer. Specifically, participants in those studies experienced less swelling and felt better overall. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06837480

Photobiomodulation in Head and Neck Cancer-Related ... The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy. What is the study measuring? Primary Outcome Measures ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8366198/

Photobiomodulation Therapy in Head and Neck Cancer ... The LTU-904 is a Class I laser device, which is a low output laser that emits a pulsed 904-nm beam at an average output of 5 mW, spot size of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06837480?locStr=United+States&country=United+States

Photobiomodulation in Head and Neck Cancer-Related ... The RianCorp LTU-904 laser therapy (sham/inactive laser device) unit will be used for sham therapy. What is the study measuring? Primary Outcome Measures ...

4. ctv.veeva.com ctv.veeva.com/study/phase-ii-rct-of-photobiomodulation-in-head-and-neck-chronic-lymphedema

Photobiomodulation in Head and Neck Cancer-Related ... Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck ...

5. withpower.com withpower.com/trial/photobiomodulation-therapy-for-head-and-neck-cancers-2c0a9

Photobiomodulation Therapy for Head and Neck Cancers 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 ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15347354211037938

Photobiomodulation Therapy in Head and Neck Cancer ... The objective of this study was to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/K030295.pdf

k030295 - accessdata.fda.gov The LTU-904 Laser Therapy Unit is a hand-held battery powered treatment device, is non-thermal and delivers a controlled series of 200 ns bursts of pulses of ...