Clinical trial NCT02036957: MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dermatitis, Adverse Drug Reaction
Keywords: capecitabine
dermatologic toxicity
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2014-01-15
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* Sign the informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of patients who develop dermatologic toxicity.
timeFrame: 3 moths
Secondary outcomes:
measure: Need of pharmacological treatment to mitigate toxicity
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Percentaje of patients who have reduces skin toxicity
timeFrame: 3 months
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: University hospital of Araba
state: Álava
Study officials:
affiliation: Basque Health Service (Research Unit)
name: Arantza Sáez de la Fuente, Msc
role: STUDY_CHAIR
affiliation: Basque Health Service (Research Unit)
name: Patricia Seaone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Basque Health Service (Research Unit)
name: Raquel Cobos, Msc
role: STUDY_CHAIR
References: