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MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY

NCT02036957 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2016-08-02

No results posted yet for this study

Summary

Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .

Design: Randomized clinical trial phase II, in parallel and double-blind groups

Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.

Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.

Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model

Conditions

  • Dermatitis, Adverse Drug Reaction

Interventions

PROCEDURE

BALM ARM

The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.

PROCEDURE

PLACEBO ARM

The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Principal Investigators

  • Arantza Sáez de la Fuente, Msc · Basque Health Service (Research Unit)

  • Patricia Seaone, MD · Basque Health Service (Research Unit)

  • Raquel Cobos, Msc · Basque Health Service (Research Unit)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02036957 on ClinicalTrials.gov