Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Prospective Study of Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting - a Phase II Study
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Informed consent
- Patient will receive palliative radiation therapy considered emetogenic for bone metastases.
- Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet
- Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting Data Collection Sheet
Exclusion Criteria:
- Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
- Patient received cranial RT within 7 days prior to commencement of protocol RT.
- Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
- Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
- Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol RT.
- Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol RT.
- Patient is allergic to protocol medication.
- Patient has a Karnofsky Performance Status score <40.
- Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Secondary prophylaxis
Patients already experiencing mild nausea/vomiting within 24 hours before radiotherapy.
Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx.
608 hours later in the day (bid).
For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment.
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Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid).
For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
다른 이름들:
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실험적: Primary prophylaxis
Patients experiencing no nausea and vomiting 24 hours before commencement of radiotherapy.
Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx.
608 hours later in the day (bid).
For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment.
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Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid).
For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
기간: Day 0 - Day 10
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The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication. |
Day 0 - Day 10
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
기간: Day 0-5 during treatment
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Quality of life as measured by the EORTC QLQ-C15-PAL.
For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable.
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
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Day 0-5 during treatment
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The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
기간: Day 6-10 of treatment
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Quality of life as measured by the EORTC QLQ-C15-PAL.
For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable.
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
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Day 6-10 of treatment
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Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
기간: Day 3
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Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with "1" being no symptoms and "not at all" for interference with life, and "7" being "a great deal" of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to "during the past 3 days". Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family? |
Day 3
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Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
기간: Day 7
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Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with "1" being no symptoms and "not at all" for interference with life, and "7" being "a great deal" of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to "during the past 3 days". Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family? |
Day 7
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공동 작업자 및 조사자
수사관
- 수석 연구원: Edward Chow, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Ondissolve
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