Using light therapy to treat hand-foot syndrome in cancer patients
Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
NA · Jessa Hospital · NCT04979078
This study is testing whether light therapy can help cancer patients with hand-foot syndrome feel better and improve their quality of life during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jessa Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Hasselt, Limburg and 1 other locations) |
| Trial ID | NCT04979078 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of photobiomodulation therapy (PBMT) in managing hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR) in cancer patients undergoing chemotherapy or targeted therapies. PBMT is a non-invasive treatment that uses specific wavelengths of light to promote healing and reduce pain and inflammation. The study aims to assess the reduction in severity of HFS and HFSR, improve quality of life, and evaluate patient satisfaction and safety over a period of time. Participants will receive PBMT and be monitored for symptom relief and overall well-being.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with cancer who are experiencing grade 1-3 hand-foot syndrome or hand-foot skin reaction due to chemotherapy or targeted therapies.
Not a fit: Patients with pre-existing skin conditions or those with unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly alleviate pain and improve the quality of life for cancer patients suffering from hand-foot syndrome.
How similar studies have performed: While the use of photobiomodulation therapy is gaining interest, this specific application for hand-foot syndrome in cancer patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with cancer of different aetiologies * Undergoing chemotherapy or targeted therapy (TKIs) * Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5) * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent Exclusion Criteria: * Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot) * Known allergy to polyurethane * Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Where this trial is running
Hasselt, Limburg and 1 other locations
- Hasselt University — Hasselt, Limburg, Belgium (NOT_YET_RECRUITING)
- Jessa Ziekenhuis VZW — Hasselt, Limburg, Belgium (RECRUITING)
Study contacts
- Principal investigator: Jeroen Mebis, MD, PhD — Head of Medical Oncology Department
- Study coordinator: Jeroen Mebis, MD, PhD
- Email: Jeroen.mebis@jessazh.be
- Phone: +32 11 33 72 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hand-foot Syndrome, Hand-foot Skin Reaction, Dermatology, Oncology, Photobiomodulation, Skin toxicity, Hand-foot syndrome, Hand-foot skin reaction