The effectiveness and cost effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea

Not Applicable

Completed

• Conditions: Chemotherapy-related acute and delayed nausea; Cancer; Chemotherapy associated nausea

• Registration Number: ISRCTN87604299
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23803562 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23602325 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-03
• Study Completion: 2010-10-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Patients of either gender and older than 16 years old
2. Patients scheduled to receive their first chemotherapy cycle
3. Patients scheduled to receive highly, moderately and low emetogenic chemotherapy (as per American Society of Clinical Oncology [ASCO] and Multinational Association of Supportive Care in Cancer [MASCC] classifications)
4. Patients scheduled to receive a chemotherapy regime given as a single administration at the beginning of the cycle repeated in 3-week cycles
5. Patients who are acupressure wristband-naïve (in terms of never having tried for themselves such a wristband, although they may have seen or heard about such wristbands)
6. Patients with any cancer diagnosis receiving adjuvant chemotherapy
7. Patients receiving chemotherapy as outpatients
8. Patients willing to participate in the study and be randomised into one of the three study groups

Exclusion Criteria

1. Patients scheduled to receive radiotherapy concurrently with chemotherapy and during the assessment period of four cycles for each patient
2. Patients unable to self care (i.e. unable to use wristbands appropriately; mental incapacity preventing continuous and optimal use of wristbands) as judged by the investigators
3. Patients with liver disease (as nausea is common presenting symptom)
4. Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting)
5. Patients with mechanical risk factors for nausea (i.e. intestinal obstruction)
6. Patients receiving chemotherapy regimens as inpatients
7. Patients experiencing nausea and/or vomiting due to use of opioids
8. Patients with lymphoedematous arms
9. Patients with chronic alcohol use (as it is associated with minimal levels of nausea and/or vomiting)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ausea experience, assessed by the Rhodes Index of Nausea and Vomiting on following days of chemotherapy: -1, 0, 1, 2, 3, 4, 5, 6 (4 cycles)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Vomiting experience, assessed by the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) on Day 10 of chemotherapy cycle (4 cycles)<br> 2. Nausea and vomiting occurrence, assessed by the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) on Day 10 of chemotherapy cycle (4 cycles)<br> 3. Quality of Life, assessed by the Functional Assessment of Cancer Therapy (FACT-G) at baseline and on Day 10 of chemotherapy cycle (4 cycles)<br> 4. Costs<br>