A systematic review of methodologies, endpoints, and outcome measures in randomized trials of radiation therapy-induced nausea and vomiting

Dennis, Kristopher; Jamani, Rehana; McGrath, Clare; Makhani, Leila; Lam, Henry; Bauer, Patrick; DeAngelis, Carlo; Coburn, Natalie; Wong, Cindy; Chow, Edward

doi:10.1007/s00520-017-3685-9

Cited by 6 publications

(11 citation statements)

References 81 publications

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“…Unfortunately, this is not always done. A systematic review of 34 phase III RINV trials showed that no trials reported their operational definition of nausea [7]. Most of our patients strongly agreed or agreed with the provided MASCC definition of nausea so it seems reasonable to use this moving forward.…”

Section: Discussionmentioning

confidence: 68%

“…Although it is more common to see qualitative grading scales for nausea in antiemetic clinical trials [7], our patients preferred an ordinal scale. It may be that they were influenced by their familiarity with this type of scale, however.…”

Section: Discussionmentioning

confidence: 93%

“…An interview guide was developed to address three main areas: symptom definitions, nausea grading scales and sub-features (Appendix A). We incorporated into its design, material from previous CINV interview guides [3] , [5] , a systematic review of endpoints and outcome measures in randomized trials of RINV [7] , and other antiemetic questionnaires commonly used in oncology [13] , [14] , [15] , [16] , [17] . Interviews were semi-structured with discrete-choice and open-ended questions.…”

Section: Methodsmentioning

confidence: 99%

“…If they strongly disagreed, disagreed or neither agreed nor disagreed they were asked what would improve the definition. Next, patients were shown five common nausea grading systems used in antiemetic clinical trials: the scale from the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 manual, a visual analogue scale (VAS) with anchors of 0 and 100 on a horizontal line, an ordinal scale with numbers from 0 to10 equally spaced on a horizontal line, a short qualitative scale with four options (none, mild, moderate, severe), and a long qualitative scale with five descriptive options (Appendix A) [3,7,13,17]. Patients indicated on a 5-point Likert-type scale how much they agreed with the scales being easy to understand and use.…”

Section: Interview Guide and Interviewsmentioning

confidence: 99%

“…Patients can confuse it with other symptoms. Reviews of RINV and CINV trials show great variability in how nausea is defined, measured and reported [3] , [7] , [8] , [9] and many important open questions remain in the study of this symptom. Do all patients define nausea similarly?…”

Section: Introductionmentioning

confidence: 99%

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Exploring the nausea experience among female patients with breast cancer; A pilot interview study

McGrath

Chang

Dennis

2020

Technical Innovations & Patient Support in Radiation Oncolo

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Introduction: Nausea is a difficult symptom to report and measure in clinical trials. We conducted a pilot interview study to improve our understanding of the nausea experience. Materials and methods: Female patients with breast cancer that had experienced nausea during radiation therapy and/or chemotherapy underwent semi-structured interviews that focused on patient-defined and standard definitions, preferences for nausea grading scales, and nausea sub-features: intensity, location, timing/duration, character, associated symptoms, precipitating/alleviating factors, impact on quality of life. Results: 10 patients were interviewed. Patients defined nausea more variably than vomiting and retching/dry heaving. An ordinal grading scale with a 0-10 intensity range was preferred over visualanalogue and qualitative scales. Patients had experienced different intensities of nausea and deemed reporting their worst, average and least intensities feasible. High-intensity episodes were deemed more problematic than low-intensity episodes regardless of their duration. The duration and character of nausea were difficult to describe. A range of associated symptoms, precipitating and alleviating factors were documented. Nausea had a detrimental impact on quality of life. Conclusions: Nausea has a range of subjective and objective features. Our pilot study provided valuable information that will inform the design of a planned larger survey study. Creating an operational clinical trial definition for nausea appears feasible.

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Section: Discussionmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 93%

Section: Methodsmentioning

confidence: 99%

Section: Interview Guide and Interviewsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Exploring the nausea experience among female patients with breast cancer; A pilot interview study

McGrath

Chang

Dennis

2020

Technical Innovations & Patient Support in Radiation Oncolo

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2023 Updated MASCC/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting

Ruhlmann,

Jordan,

Jahn

et al. 2023

Support Care Cancer

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Purpose Radiotherapy and chemoradiotherapy-induced nausea and vomiting (RINV and C-RINV) are common and distressing, and there is a need for guidance for clinicians to provide up to date optimal antiemetic prophylaxis and treatment. Through a comprehensive review of the literature concerning RINV and C-RINV, this manuscript aims to update the evidence for antiemetic prophylaxis and rescue therapy and provide a new edition of recommendations for the MASCC/ESMO antiemetic guidelines for RINV and C-RINV. Methods A systematic review of the literature including data published from May 1, 2015, to January 31, 2023, was performed. All authors assessed the literature. Results The searches yielded 343 references; 37 met criteria for full article review, and 20 were ultimately retained. Only one randomized study in chemoradiation had the impact to provide new recommendations for the antiemetic guideline. Based on expert consensus, it was decided to change the recommendation for the “low emetic risk” category from “prophylaxis or rescue” to “rescue” only, while the drugs of choice remain unchanged. Conclusion As for the previous guideline, the serotonin receptor antagonists are still the cornerstone in antiemetic prophylaxis of nausea and vomiting induced by high and moderate emetic risk radiotherapy. The guideline update provides new recommendation for the management of C-RINV for radiotherapy and concomitant weekly cisplatin. To avoid overtreatment, antiemetic prophylaxis is no longer recommended for the “low emetic risk” category.

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Nausea and Vomiting in Advanced Cancer

Navari

2020

Curr. Treat. Options in Oncol.

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A systematic review of methodologies, endpoints, and outcome measures in randomized trials of radiation therapy-induced nausea and vomiting

Abstract: Methodologies, endpoints, and outcome measures varied considerably among 34 randomized trials in RINV.

Cited by 6 publications

References 81 publications

Exploring the nausea experience among female patients with breast cancer; A pilot interview study

Exploring the nausea experience among female patients with breast cancer; A pilot interview study

2023 Updated MASCC/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting

Nausea and Vomiting in Advanced Cancer

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