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Management of chemotherapy-induced nausea and vomiting: A pilot randomised controlled trial using Nevasic audio programme.

Moradian, Saeed

[Thesis]. Manchester, UK: The University of Manchester; 2013.

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Abstract

Major advances in antiemetic therapy have been made over the past two decades. Despite these advances in antiemetic management, nausea and vomiting are still important problems in clinical practice, and approximately 50% of patients receiving chemotherapy still experience nausea and/or vomiting, highlighting the need for further developments in the field. Non-pharmacological interventions are suggested as possible adjuncts to standard anti-emetic therapy. A recently developed non-pharmacological intervention to alleviate nausea and vomiting is Nevasic, which may have potential to reduce CINV and improve management of these symptoms.This pilot trial was run to examine the feasibility of implementing and conducting a randomised controlled trial using Nevasic programme. In addition, the study aimed to evaluate the acceptability and potential effect of Nevasic on cancer patients undergoing chemotherapy. Ninety nine adult female breast cancer patients who had been prescribed a course of moderately high emetogenic chemotherapy were randomised to usual care (standard anti-emetics) plus one of (1) intervention group (using Nevasic), (2) attention group (listening to music), and (3) control group, receiving no additional intervention. Data were collected daily using the Rhodes Index of Nausea, Vomiting and Retching (INVR) and a structured diary questionnaire. The EORTC QLQ-C30 (and BR23) were used at baseline and day 6 post chemotherapy. Data were collected from cancer centres affiliated to Mashhad University of Medical Sciences in Mashhad, Iran.The findings from the trial highlight that conducting a non-pharmacological intervention using such an audio programme is feasible, although difficulties and limitations exist. This study did not detect any evidence for the effectiveness of Nevasic on CINV; however, the results show statistically significant less use of anti-emetics (post-chemotherapy) (p=0.03) and borderline non-significant (p=0.06) better global health status in Nevasic group. Further studies are required to investigate its implications from other perspectives such as use of anti-emetics - rather than looking only at the "level of nausea and/or vomiting" perspective.

Layman's Abstract

Background: Despite advances in antiemetic management, nausea and vomiting are still important problems in clinical practice, and approximately 50% of patients receiving chemotherapy still experience nausea and/or vomiting, highlighting the need for further developments in the field. Non-pharmacological interventions are suggested as possible adjuncts to standard anti-emetic therapy.Objective: To examine the feasibility of implementing and conducting a randomised controlled trial (RCT) using Nevasic audio programme and to evaluate the acceptability and potential effect of Nevasic on cancer patients undergoing chemotherapy. Methods: Ninety nine adult female breast cancer patients who had been prescribed a course of moderately high emetogenic chemotherapy were randomised to usual care (standard anti-emetics) plus one of (1) intervention group (using Nevasic), (2) attention group (listening to music), and (3) control group, receiving no additional intervention. Data were collected daily using the Rhodes Index of Nausea, Vomiting and Retching (INVR) and a structure diary questionnaire. The EORTC QLQ-C30 (plus BR23) were used at baseline and day 6 post chemotherapy. Data were collected from cancer centres affiliated to Mashhad University of Medical Sciences in Mashhad (MUMS), Iran.Results: The findings from the trial highlight that conducting a non-pharmacological intervention using such an audio programme is feasible, although difficulties and limitations exist. This study did not detect any evidence for the effectiveness of Nevasic on chemotherapy induced nausea and vomiting (CINV); however, the results show statistically significant less use of anti-emetics (post-chemotherapy) (p=0.03) and borderline non-significant (p=0.06) better global health status in Nevasic group.Limitations: This pilot trial was not powered to prevent the risk of type I or type II errors.Conclusions: Further studies are required to investigate Nevasic implications from other perspectives such as use of anti-emetics - rather than looking only at the "level of nausea and/or vomiting" perspective.

Bibliographic metadata

Type of resource:
Content type:
Form of thesis:
Type of submission:
Degree programme:
PhD Nursing
Publication date:
Location:
Manchester, UK
Total pages:
365
Abstract:
Major advances in antiemetic therapy have been made over the past two decades. Despite these advances in antiemetic management, nausea and vomiting are still important problems in clinical practice, and approximately 50% of patients receiving chemotherapy still experience nausea and/or vomiting, highlighting the need for further developments in the field. Non-pharmacological interventions are suggested as possible adjuncts to standard anti-emetic therapy. A recently developed non-pharmacological intervention to alleviate nausea and vomiting is Nevasic, which may have potential to reduce CINV and improve management of these symptoms.This pilot trial was run to examine the feasibility of implementing and conducting a randomised controlled trial using Nevasic programme. In addition, the study aimed to evaluate the acceptability and potential effect of Nevasic on cancer patients undergoing chemotherapy. Ninety nine adult female breast cancer patients who had been prescribed a course of moderately high emetogenic chemotherapy were randomised to usual care (standard anti-emetics) plus one of (1) intervention group (using Nevasic), (2) attention group (listening to music), and (3) control group, receiving no additional intervention. Data were collected daily using the Rhodes Index of Nausea, Vomiting and Retching (INVR) and a structured diary questionnaire. The EORTC QLQ-C30 (and BR23) were used at baseline and day 6 post chemotherapy. Data were collected from cancer centres affiliated to Mashhad University of Medical Sciences in Mashhad, Iran.The findings from the trial highlight that conducting a non-pharmacological intervention using such an audio programme is feasible, although difficulties and limitations exist. This study did not detect any evidence for the effectiveness of Nevasic on CINV; however, the results show statistically significant less use of anti-emetics (post-chemotherapy) (p=0.03) and borderline non-significant (p=0.06) better global health status in Nevasic group. Further studies are required to investigate its implications from other perspectives such as use of anti-emetics - rather than looking only at the "level of nausea and/or vomiting" perspective.
Layman's abstract:
Background: Despite advances in antiemetic management, nausea and vomiting are still important problems in clinical practice, and approximately 50% of patients receiving chemotherapy still experience nausea and/or vomiting, highlighting the need for further developments in the field. Non-pharmacological interventions are suggested as possible adjuncts to standard anti-emetic therapy.Objective: To examine the feasibility of implementing and conducting a randomised controlled trial (RCT) using Nevasic audio programme and to evaluate the acceptability and potential effect of Nevasic on cancer patients undergoing chemotherapy. Methods: Ninety nine adult female breast cancer patients who had been prescribed a course of moderately high emetogenic chemotherapy were randomised to usual care (standard anti-emetics) plus one of (1) intervention group (using Nevasic), (2) attention group (listening to music), and (3) control group, receiving no additional intervention. Data were collected daily using the Rhodes Index of Nausea, Vomiting and Retching (INVR) and a structure diary questionnaire. The EORTC QLQ-C30 (plus BR23) were used at baseline and day 6 post chemotherapy. Data were collected from cancer centres affiliated to Mashhad University of Medical Sciences in Mashhad (MUMS), Iran.Results: The findings from the trial highlight that conducting a non-pharmacological intervention using such an audio programme is feasible, although difficulties and limitations exist. This study did not detect any evidence for the effectiveness of Nevasic on chemotherapy induced nausea and vomiting (CINV); however, the results show statistically significant less use of anti-emetics (post-chemotherapy) (p=0.03) and borderline non-significant (p=0.06) better global health status in Nevasic group.Limitations: This pilot trial was not powered to prevent the risk of type I or type II errors.Conclusions: Further studies are required to investigate Nevasic implications from other perspectives such as use of anti-emetics - rather than looking only at the "level of nausea and/or vomiting" perspective.
Additional digital content not deposited electronically:
None
Thesis main supervisor(s):
Thesis co-supervisor(s):
Thesis advisor(s):
Funder(s):
Language:
en

Institutional metadata

University researcher(s):

Record metadata

Manchester eScholar ID:
uk-ac-man-scw:198788
Created by:
Moradian, Saeed
Created:
24th June, 2013, 10:18:40
Last modified by:
Moradian, Saeed
Last modified:
25th July, 2013, 10:28:02

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