MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY (B-DUOL)

EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.

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

Study Overview

• Status: Unknown
• Conditions: Dermatitis, Adverse Drug Reaction
• Intervention / Treatment: Procedure: BALM ARM; Procedure: PLACEBO ARM

Detailed Description

Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine

The product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.

The product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.

The patient will not apply any other cosmetic product in the treated areas.

In addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.

The study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. In these patients the total duration of the study must be sufficient to end the eighth cycle.

If the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Patricia Seaone, MD; Phone Number: 945007000

Study Locations

• Spain
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Recruiting
      • University hospital of Araba
      • Contact: Arantza Saez de Lafuente
      • Principal Investigator: Carlos Peña

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Over 18 years.
• Sign the informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BALM ARM; 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; 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 Comparator: PLACEBO ARM; It be applicated in like manner that balm arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of pharmacological treatment to mitigate toxicity	Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy	3 months
Quality of life	Compare the quality of life in both groups at three months, through the Skindex 29 scale to evaluate the quality of life due to skin disease.	3 months
Percentaje of patients who have reduces skin toxicity		3 months

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Study Chair: Arantza Sáez de la Fuente, Msc, Basque Health Service (Research Unit); Principal Investigator: Patricia Seaone, MD, Basque Health Service (Research Unit); Study Chair: Raquel Cobos, Msc, Basque Health Service (Research Unit)

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: capecitabine; dermatologic toxicity
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Immune System Diseases; Hypersensitivity; Drug Hypersensitivity; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions
• Other Study ID Numbers: MD-01