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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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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.
時間枠：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.
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Edward Chow, MBBS PhD、Odette Cancer Centre, Sunnybrook Health Sciences Centre
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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