MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY (B-DUOL)
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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Álava
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Vitoria-Gasteiz, Álava, 스페인, 01009
- 모병
- University hospital of Araba
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연락하다:
- Arantza Saez de Lafuente
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수석 연구원:
- Carlos Peña
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Over 18 years.
- Sign the informed consent
Exclusion Criteria:
- Patients with neoadjuvant treatment.
- Patients with dermatologic diseases.
- Patients treated with corticosteroids.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated.
The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption.
Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
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위약 비교기: PLACEBO ARM
It be applicated in like manner that balm arm
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The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated.
The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption.
Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of patients who develop dermatologic toxicity.
기간: 3 moths
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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).
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3 moths
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Need of pharmacological treatment to mitigate toxicity
기간: 3 months
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Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy
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3 months
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Quality of life
기간: 3 months
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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.
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3 months
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Percentaje of patients who have reduces skin toxicity
기간: 3 months
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3 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Arantza Sáez de la Fuente, Msc, Basque Health Service (Research Unit)
- 수석 연구원: Patricia Seaone, MD, Basque Health Service (Research Unit)
- 연구 의자: Raquel Cobos, Msc, Basque Health Service (Research Unit)
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MD-01
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