Clinical trial NCT05337423: Photobiomodulation in the Treatment of Hand-foot Syndrome
Official title: Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erythrodysesthesia Syndrome
Keywords: Hand-Food Syndrome
Low-Level Light Therapy
Quality of life
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Group of participants will receive skin moisturizer and photobiomodulation sham while another group will receive the skin moisturizer and the active photobiomodulation treatment.
Primary purpose: TREATMENT

Brief summary: A cytotoxic complication caused by chemotherapy is hand-foot syndrome, also known as palmar-plantar erythrodysesthesia (PPE). The mechanism is not yet clear, but it is thought that the chemotherapeutic agent generates cytotoxicity on the acral epidermis. Clinically it manifests as erythema and edema on the palms of the hands and feet, dry and scaly skin, accompanied by a sensation of tightness and pain. Extreme cases present blisters and ulcerations that may require hospitalization. It can also be accompanied by paresthesias. The main objective will be to evaluate if photobiomodulation is effective in reducing PPE induced by Capecitabine and 5-Fluorouracil chemotherapy.

It will be a 4 week treatment, with 2 groups: G1 - Moisturizing cream and Photobiomodulation; G2: Moisturizing cream and photobiomodulation sham.

Detailed description: Methodology: randomized, controlled, double-blind, single-center clinical trial. The study population (40 participants) will be divided into two groups - Group 1: moisturizer plus LED (light emitting diode) treatment and Group 2: moisturizer plus LED sham treatment. For the application of LED light, Antares (ibramed) with P2 LED cluster (630 nm) will be applied twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks.

The Palmar-plantar Erythrodysesthesia (PPE) degree is the main outcome while the secondary outcomes are the data referring to the chemotherapy treatment plan (Chemotherapy dose, need of reducing drug dose or interrupting the treatment) and also the quality of life by using Hand-foot syndrome (HSF) questionnaire - HSF-14 and dermatology Life Questionnaire Index (DLQI). PPE grade and chemotherapy plan will be measured prior to the start of treatment with photobiomodulation, in the middle and at the end of it. Quality of life questionnaires (HFS-14 - Hand-foot syndrome and DLQI - dermatology Life Questionnaire Index) will be applied at the beginning and at the end of the treatment.

Eligibility 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.

Primary outcomes:
measure: Palmo planar erythrodysesthesia grade
timeFrame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Secondary outcomes:
measure: Chemotherapy dose
timeFrame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
measure: Need of interrupting chemotherapy
timeFrame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
measure: Need of reducting chemotherapy dose
timeFrame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
measure: HSF-14
timeFrame: Before treatment (Day 0) and at the end of the treatment (Day 28)
measure: DLQI
timeFrame: Before treatment ( Day 0) and the end of the treatment (Day 28)
measure: Questionnaire
timeFrame: Follow up (day 60)
measure: Peripheral Sensory Neuropathy World Health Organization (WHO) Scale
timeFrame: Before treatment ( Day 0) and the end of the treatment (Day 28)
measure: Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale
timeFrame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Centro de Asistencia del Sindicato Médico del Uruguay
city: Montevideo
country: Uruguay
facility: Instituto Nacional del Cáncer
Study officials:
affiliation: Universidad Catolica de Uruguay
name: Valentina Lestido, Master
role: PRINCIPAL_INVESTIGATOR
References: