Photobiomodulation Therapy for Head and Neck Cancers

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group

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.

Research Team

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.

Treatment Details

Interventions

• LTU-904 Portable Laser Therapy Unit (Device)

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+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School