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

Phase 2

Waitlist Available

Research Sponsored by Instituto Brasileiro de Controle do Cancer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

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.

Eligible Conditions

Hand-Foot Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Palmar-plantar erythrodysesthesia syndrome

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

Incidence of cessation of capecitabine therapy

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExtremecareExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

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