Dermatitis, Adverse Drug Reaction Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention