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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87604299
Enrollment
699
Registered
2008-06-03
Start date
2008-11-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-related acute and delayed nausea Cancer Chemotherapy associated nausea

Interventions

This trial is testing the effect of acupressure wristbands using two acupressure groups and a standard care group (three-arm trial). In the first acupressure group, in addition to standard antiemetics

Sponsors

University of Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Nausea 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

MeasureTime frame
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) 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) 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) 4. Costs

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026