Erythrodysesthesia Syndrome
Conditions
Keywords
Hand-Food Syndrome, Low-Level Light Therapy, Quality of life
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.
Interventions
DEVICEPhotobiomodulation
Group 1 will receive 630 nm LED and group 2 will receive sham treatment twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks.
OTHERMoisturizer
Both groups will receive moisturizer.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palmo planar erythrodysesthesia grade | Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28) | 3 Epp grades were stablished by CTC NCI being: Grade 1 - Minimal palmoplantar skin changes, without pain (erythema, edema, hyperkeratosis),; grade 2 - Skin changes (scaling, blisters, fissures, edema, hyperkeratosis) with pain, limiting instrumental activities; grade 3 - Severe skin changes (scaling, blisters, fissures, edema, hyperkeratosis, bleeding), with pain.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of interrupting chemotherapy | Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28) | The need of interrupting chemotherapy due to Palmo planar erythrodysesthesia : Yes or no |
| Need of reducting chemotherapy dose | Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28) | The need of reducing dose of chemotherapy due to Palmo planar erythrodysesthesia: Yes or no |
| HSF-14 | Before treatment (Day 0) and at the end of the treatment (Day 28) | Quality of life questionnaire HSF-14 |
| Chemotherapy dose | Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28) | Total dose (mg) of chemotherapeutical drug used |
| Questionnaire | Follow up (day 60) | Questionnaire developed by researchers evaluating parameters in hands and feet related to daily activities. |
| Peripheral Sensory Neuropathy World Health Organization (WHO) Scale | Before treatment ( Day 0) and the end of the treatment (Day 28) | Peripheral Sensory Neuropathy World Health Organization (WHO) Scale Grade 0: No; grade 1: symptoms Presence of paresthesias and/ or decreased deep tendon reflexes; Grade 2: Severe paresthesias and/or light muscle weakness Grade 3: Intolerable paresthesias and/or marked weakness , Grade 4: Paralysis |
| Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale | Before treatment ( Day 0) and the end of the treatment (Day 28) | Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale Grade 0, None, or no change; Grade 1: Loss of deep tendon reflexes, mild paresthesias. Grade 2: Mild or moderate objective sensory loss; moderate paresthesias. Grade 3: Severe objective sensory loss, or paresthesias that interfere with function |
| DLQI | Before treatment ( Day 0) and the end of the treatment (Day 28) | Quality of life questionnaire - Dermatology life quality index |
Countries
Uruguay
Outcome results
None listed