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

Phase 1

• Conditions: Dermatitis, Adverse Drug Reaction
• Interventions: Procedure: PLACEBO ARM; Procedure: BALM ARM

• Registration Number: NCT02036957
• Lead Sponsor: Basque Health Service

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

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 Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2014-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Over 18 years.
• Sign the informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO ARM	PLACEBO ARM	It be applicated in like manner that balm arm
BALM ARM	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients who develop dermatologic toxicity.	3 moths	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).

Secondary Outcome Measures

Name	Time	Method
Percentaje of patients who have reduces skin toxicity	3 months
Need of pharmacological treatment to mitigate toxicity	3 months	Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy
Quality of life	3 months	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.

Trial Locations

Locations (1)

University hospital of Araba; 🇪🇸 Vitoria-Gasteiz, Álava, Spain