부인과암에서 화학요법으로 인한 말초 신경병증을 감소시키기 위한 냉동 압박 - COHORT 2
부인과암에서 화학요법으로 인한 말초 신경병증을 감소시키기 위한 저온 압박의 사용: 무작위 대조 시험 - COHORT 2
The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.
연구 개요
상세 설명
Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Amelia Scott
- 전화번호: 919-613-4584
- 이메일: amelia.lorenzo@duke.edu
연구 장소
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Connecticut
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Hartford, Connecticut, 미국, 06106
- 모병
- Hartford Healthcare Cancer Institute
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수석 연구원:
- Amy Brown, MD
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연락하다:
- Siobhan Reilly
- 전화번호: 860-696-4958
- 이메일: Siobhan.Reilly@hhchealth.org
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Middletown, Connecticut, 미국, 06457
- 모병
- Middlesex Health Cancer Center - Middletown
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수석 연구원:
- Karthikeyan Kandevelou, MD
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연락하다:
- Loriann MacLean, MSN
- 전화번호: (860)358-2015
- 이메일: loriann.maclean@midhosp.org
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North Carolina
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Durham, North Carolina, 미국, 27710
- 모병
- Duke University Medical Center
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수석 연구원:
- Laura Havrilesky, MD
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연락하다:
- Amelia Scott
- 전화번호: (919) 613-4584
- 이메일: amelia.lorenzo@duke.edu
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Virginia
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Roanoke, Virginia, 미국, 24016
- 모병
- Carilion Clinic
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수석 연구원:
- Erin Saks, MD
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연락하다:
- Anna Derrick
- 전화번호: 540-581-0160
- 이메일: acderrick@carilionclinic.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
- Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Exclusion Criteria:
- Treated with prior neurotoxic chemotherapeutic agents
- Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 크라이오테라피
|
Participants will receive cryotherapy on both hands and feet |
|
실험적: 냉동요법을 이용한 압박
|
Participants will receive cryotherapy on both hands and feet Participants will receive compression on both hands and feet |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
The FACT-NTX is a patient self-reported 11-item questionnaire used for evaluating symptoms and concerns specifically associated with chemotherapy induced neuropathy. The total score ranges from 0-44, and a lower FACT-NTX score corresponds to worsening neuropathy. For both the FACT-NTX and the sensory subscale of the FACT-NTX, a significant decrease in the score is defined as a decrease exceeding 10% from baseline. |
Up to two months after completion of chemotherapy, an average of 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tolerability of cryocompression: scale
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression tolerability assessment after each chemotherapy session in which they will answer the question, "How tolerable was the cryocompression procedure for you?" on a scale from 0 to 100. A score of 0 means "not tolerable at all" and a score of 100 is "very tolerable". Pain, abnormal sensation, and adherence to cryocompression will also be evaluated as patient-reported measures of tolerability. |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Acceptability: scale
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
Subjects will be asked to complete a cryocompression acceptability assessment after each chemotherapy session in which they answer the questions, "How acceptable was the cryocompression procedure to you?" and "How likely are you to continue with cryocompression at your next chemotherapy treatment?" on a scale from 0 to 100, with 0 being "not acceptable, not likely to continue" and 100 being "very acceptable, very likely to continue". |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Measure of manageability and acceptability for staff involved in the participants' care
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
Staff will be asked to complete an acceptability assessment after each chemotherapy session in which they will answer the question, "How manageable or acceptable was this patient's cryotherapy/cryocompression therapy to you in working with a patient receiving chemotherapy?" on a scale from 0 to 100. A score of 0 means "not at all acceptable" and a score of 100 is "complete acceptable". They will also be asked "In your experience, compare the ease of use of the cryotherapy wrap versus plastic ice bags" on a scale from 0 to 100. A score of 0 means "cryotherapy wraps are much harder," and a score of 100 means "cryotherapy wraps are much easier." |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living [ADL]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL). |
Up to two months after completion of chemotherapy, an average of 6 months
|
|
Chemotherapy Dose
기간: Up to two months after completion of chemotherapy, an average of 6 months
|
Study staff will record the taxol dose at each cycle |
Up to two months after completion of chemotherapy, an average of 6 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Laura Havrilesky, DUHS
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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