Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine

NCT04833998 | Unknown Phase 2

• 1 other identifier: 01629018.1.0000.0072
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL). The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS. It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome. The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.

Conditions

Hand-foot Syndrome

Keywords

Hand-foot Syndrome; Palmoplantar Erythrodysesthesia; Acral Erythema; Capecitabine; Moisturizing cream

Outcome Measures

Primary Outcomes (1)

• Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.

  Number of Patients who developed Hand-foot Syndrome (HFS) by Toxicity Grade. The incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 for all patients assigned who received at least 1 cycle of capecitabine. Investigators assess and fill the grading into the case report form every visit.

  Up to 15 weeks

Secondary Outcomes (4)

• Changes in the signs of hand-foot syndrome

  Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)

• Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.

  Up to 15 weeks

• Quality of Life as Measured by Dermatology Life Quality Index (DLQI)

  Up to 15 weeks

• Incidence of cessation of capecitabine therapy

  Up to 15 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be cream without the active ingredient. It will be matched in appearance, smell, consistency, and color to Extremecare topical cream. Patients will be instructed to apply the placebo cream to the hand and feet.

Drug: Placebo

Extremecare

EXPERIMENTAL

Extremecare is a moisturizing cream based on Thoitaine, Aloe Vera and Calendula for topical use. Patients will be instructed to apply the moisturizing cream to the hand and feet.

Drug: Extremecare

Interventions

Extremecare DRUG

The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.

Extremecare

Placebo DRUG

Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age
• Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
• Indication of adjuvant or palliative treatment with capecitabine
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Information of the patient and signature of the informed consent form by the patient or her legal representative.

You may not qualify if:

• Previous chemotherapy with capecitabine
• Pre-existing patients with neuropathies
• Patients with known allergic reactions to any of the ingredients of the investigational product
• Patients with dermatological conditions that affect the hands or feet
• Patients with rectal neoplasia and indication for neoadjuvant treatment.

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead
• Wecare Comércio de Cosméticos: collaborator

Study Sites (1)

IBCC Oncologia

São Paulo, 03102002, Brazil

RECRUITING

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

Flavia Viécili Tarcha, MD

CONTACT

+55 11 99700-0316; flavinhavt@yahoo.com

Alayne Domingues Yamada, PhD

CONTACT

+55 11 98141-7613; alayne.pesquisa@ibcc-mooca.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The allocation ratio is 2:1, favouring the active treatment. In this study we are using unequal allocation ratios for a variety of reasons, including allowance for learning curves, and ethical considerations when the balance of existing evidence appears to be in favour of one intervention over the placebo.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: August 2, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

BR (1)