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MARY D&Apos;UOL REPAIR BALM IN THE PREVENTION OF SKIN TOXICITY BY CAPECITABINE

Information source: Basque Health Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatitis, Adverse Drug Reaction

Intervention: BALM ARM (Procedure); PLACEBO ARM (Procedure)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Basque Health Service

Official(s) and/or principal investigator(s):
Arantza Sáez de la Fuente, Msc, Study Chair, Affiliation: Basque Health Service (Research Unit)
Patricia Seaone, MD, Principal Investigator, Affiliation: Basque Health Service (Research Unit)
Raquel Cobos, Msc, Study Chair, Affiliation: Basque Health Service (Research Unit)

Overall contact:
Patricia Seaone, MD, Phone: 945007000

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

Clinical Details

Official title: EFFECTIVENESS OF OF MARY D&Apos;UOL REPAIR BALM TO PREVENT THE SKIN TOXICITY IN PATIENTS WITH CAPECITABINE. RANDOMIZED CLINICAL TRIAL

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Percentage of patients who develop dermatologic toxicity.

Secondary outcome:

Need of pharmacological treatment to mitigate toxicity

Quality of life

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Over 18 years.

- II or III colon cancer (Dukes' C)

- Primary diagnosis.

- Capecitabine monotherapy

- Sign the informed consent

Exclusion Criteria:

- Patients who have received chemotherapy and/or radiotherapy or other treatment

adjunct to surgery.

- Patients with neoadjuvant chemotherapy

Locations and Contacts

Patricia Seaone, MD, Phone: 945007000

University hospital of Araba, Vitoria-Gasteiz, Álava 01009, Spain; Recruiting
Arantza Saez de Lafuente
Carlos Peña, Principal Investigator
Additional Information

Starting date: February 2014
Last updated: February 9, 2015

Page last updated: August 20, 2015

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