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Clinical Trials/NCT02036957
NCT02036957UnknownPhase 1

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.

Basque Health Service2 sites in 1 country86 target enrollmentStarted: February 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Sponsor
Enrollment
86
Locations
2
Primary Endpoint
Percentage of patients who develop dermatologic toxicity.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Over 18 years.
  • Sign the informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Percentage of patients who develop dermatologic toxicity.

Time Frame: 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 Outcomes

  • Percentaje of patients who have reduces skin toxicity(3 months)
  • Need of pharmacological treatment to mitigate toxicity(3 months)
  • Quality of life(3 months)

Investigators

Sponsor
Basque Health Service
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Patricia Seoane

oncologist physician

Basque Health Service

Study Sites (2)

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