- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01695993
Alternative Approaches for Nausea Control
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.
Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
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East Syracuse, New York, 미국, 13057
- Hematology-Oncology Associates of Central New York
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Rochester, New York, 미국, 14642
- University of Rochester James P. Wilmot Cancer Center
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Rochester, New York, 미국, 14621
- Rochester General Hospital's Lipson Cancer and Blood Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Be female.
- Have a diagnosis of breast cancer, any stage.
- Be chemotherapy naïve and about to begin her first course of chemotherapy.
Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
- Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
- Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
- Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
- Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
- Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."
- Be able to read English (since the assessment materials are in printed format).
- Be 18 years of age or older and give written informed consent.
Exclusion Criteria:
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
- Be receiving concurrent radiotherapy or interferon.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Arm 1 - Standard Care Only
Patients will receive standard care only
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다른: Arm 2 - Expectancy-neutral Arm
Patients receive:
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Bilateral acupressure wrist bands
The expectancy neutral handout has neutral information regarding the acupressure bands
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
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실험적: Arm 3 - Expectancy-enhancing Arm
Patients receive:
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Bilateral acupressure wrist bands
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
It also has expectancy-enhancing information regarding the acupressure bands.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient Report Nausea Diary
기간: five days
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Nausea and will be measured by a patient report diary completed by patients over a five-day period.
Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day.
Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated."
The outcome variable for the primary analysis was greatest reported nausea from the five day period.
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five days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph A Roscoe, Ph.D., University of Rochester
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .