NCT02036957

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

January 14, 2014

Last Update Submit

August 1, 2016

Conditions

Dermatitis, Adverse Drug Reaction

Keywords

capecitabinedermatologic toxicity

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who develop dermatologic toxicity.

    Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).

    3 moths

Secondary Outcomes (3)

  • Need of pharmacological treatment to mitigate toxicity

    3 months

  • Quality of life

    3 months

  • Percentaje of patients who have reduces skin toxicity

    3 months

Study Arms (2)

BALM ARM

EXPERIMENTAL

The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. Will be applied twice a day (after showering and at night), massaging the area until completely absorption.

Procedure: BALM ARM

PLACEBO ARM

PLACEBO COMPARATOR

It be applicated in like manner that balm arm

Procedure: PLACEBO ARM

Interventions

BALM ARMPROCEDURE

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.

BALM ARM
PLACEBO ARMPROCEDURE

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.

PLACEBO ARM

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years.
  • Sign the informed consent

You may not qualify if:

  • Patients with neoadjuvant treatment.
  • Patients with dermatologic diseases.
  • Patients treated with corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Araba

Vitoria-Gasteiz, Álava, 01009, Spain

RECRUITING

MeSH Terms

Conditions

Drug Eruptions

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Arantza Sáez de la Fuente, Msc

    Basque Health Service (Research Unit)

    STUDY CHAIR

  • Patricia Seaone, MD

    Basque Health Service (Research Unit)

    PRINCIPAL INVESTIGATOR

  • Raquel Cobos, Msc

    Basque Health Service (Research Unit)

    STUDY CHAIR

Central Study Contacts

Patricia Seaone, MD

CONTACT

945007000

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oncologist physician

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 15, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations

ES(1)