Using light therapy to treat hand-foot syndrome caused by chemotherapy
Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
This study is testing if light therapy can help reduce hand-foot syndrome caused by chemotherapy in people undergoing treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy |
| Locations | 2 sites (Montevideo and 1 other locations) |
| Trial ID | NCT05337423 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of photobiomodulation, a form of low-level light therapy, in reducing hand-foot syndrome (palmar-plantar erythrodysesthesia) induced by chemotherapy agents like Capecitabine and 5-Fluorouracil. The study involves a randomized, controlled, double-blind design with 40 participants divided into two groups: one receiving LED treatment alongside a moisturizer and the other receiving a sham treatment with the same moisturizer. Outcomes will be assessed based on the severity of hand-foot syndrome and quality of life measures before, during, and after the treatment period of four weeks.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with confirmed oncological conditions who are currently undergoing chemotherapy and experiencing moderate to severe hand-foot syndrome.
Not a fit: Patients with pre-existing skin conditions on the palms and soles, autoimmune diseases, or those requiring insulin for diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate the painful symptoms of hand-foot syndrome, improving the quality of life for patients undergoing chemotherapy.
How similar studies have performed: While the approach of using photobiomodulation is gaining interest, this specific application for hand-foot syndrome is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * over 18 years of age, * hospitalized or outpatients, * with oncological pathology (confirmed by anatomo-pathological or cytological diagnosis) * undergoing chemotherapy treatment (oral capecitabine and 5-Fluorouracil in continuous infusion, following the treatment plans protocolized by the institution: Xelox Bevacizumab, Capecitabine, Capecitabine + Radiotherapy, Folfoxiri, Xeliri-Bevacizumab, Folfox4-Bevacizumab , Docetaxel-CDDP-5-Fluorouracil (Colony Stimulating Factors), mFolfirinox q/14 days, Flot.) * who develop hand-foot syndrome of greater or equal toxicity to 1 on the CTC scale NCI v. 5.0 and on Saif scale. Et al. for dark skin Exclusion Criteria: * Patients with palmo-plantar skin comorbidities, * autoimmune comorbidities, * amputated limbs, * systemic infection, * localized or regional limb infection, * respiratory isolation, * contact isolation * insulin-requiring diabetics.
Where this trial is running
Montevideo and 1 other locations
- Centro de Asistencia del Sindicato Médico del Uruguay — Montevideo, Uruguay (Recruiting)
- Instituto Nacional del Cáncer — Montevideo, Uruguay (Recruiting)
Study contacts
- Principal investigator: Valentina Lestido, Master — Universidad Catolica de Uruguay
- Study coordinator: Valentina Lestido, Master
- Email: valentina.lestido@ucu.edu.uy
- Phone: +59894298577
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.