ISRCTN - ISRCTN87604299: The effectiveness and cost effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-acupressure-to-help-relieve-sickness-from-chemotherapy

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alexander Molassiotis

ORCID ID

Contact details

School of Nursing
Midwifery & Social Work
University Place
Manchester
M13 9PL
United Kingdom
alex.molassiotis@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/31/02

Study information

Scientific title

Acronym

ANCHoR

Study hypothesis

Primary objective:
1. To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) nausea compared to patients receiving standard care with sham acupressure wristbands and standard care alone.

Secondary objectives:
2. To assess the cost effectiveness and extent of use of usual care in patients using acupressure wristbands in addition to standard care for the management of chemotherapy-induced nausea compared to patients receiving standard care with sham acupressure wristbands and standard care alone.
3. To assess the level of quality of life in patients using acupressure wristbands in addition to standard care in the management of chemotherapy-induced nausea and vomiting compared to patients receiving standard care with sham acupressure wristbands and standard care alone.
4. To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) vomiting compared to patients receiving standard care with sham acupressure wristbands and standard care alone.
5. To ascertain for which emetogenic level of chemotherapy regimens (i.e. high, moderate or low emetogenic chemotherapy) self-acupressure using wristbands in addition to standard care is more or less effective in terms of nausea compared to patients receiving standard care with sham acupressure wristbands and standard care alone.
6. To ascertain whether any improvement in chemotherapy-induced nausea and vomiting from using acupressure wristbands is different in males and females.
7. To ascertain whether there is an age effect from the use of acupressure wristbands in relation to chemotherapy-induced nausea and vomiting.

Protocol in: http://www.hta.ac.uk/protocols/200700310002.pdf

Please note that as of 24/02/09 the acronym of this trial was amended; the initial acronym at the time of registration was: CART.

Ethics approval

Approved by Nottingham 1 Multicentre Research Ethics Committee

Study design

Multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chemotherapy-related acute and delayed nausea

Intervention

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, patients will be provided with a pair of SeaBand™ wristbands (Sea-Band Ltd, UK). These bands are elastic wristbands with a 1 cm protruding round plastic button (stud). These are available in two sizes, a standard one and a larger one. Patients wear the wristband with the stud pressing the P6 acu-point, which is located on the anterior surface of the forearm, approximately three-finger width up from the crease of the wrist between the tendons of the palmaris longus and flexor carpi radialis. Patients will be provided with a pair of acupressure wristbands and they will be instructed to wear them on both arms and take them off only when showering/bathing. An instruction sheet with a picture of point P6 and how to locate the point will also be provided to patients. Patients will be instructed to wear the wristbands from the morning before chemotherapy administration and for the subsequent 6 days (total 7 days).

In the second acupressure group, in addition to standard antiemetics, patients will be provided with a pair of the identical appearing wristbands, with the only difference being that the sham wristband will have a flat button in place of the protruding stud, thus exerting no pressure on the P6 point.

The standard care group will receive standard antiemetics alone. Standard antiemetics for all three groups will be based on the ASCO and MASCC international antiemetic guidelines with the exception of NK1 receptor antagonists (i.e. aprepitant) recommended in highly emetic chemotherapy, which is not available currently in the NHS. Hence, for highly emetic chemotherapy, patients should receive a 5-HT3 receptor antagonist (i.e. Zofran® 8 mg) and dexamethasone 8 mg intravenously before chemotherapy and the same orally for 3 days post chemotherapy; for moderately emetogenic chemotherapy a 5-HT3 receptor antagonist (Zofran® 8 mg) and dexamethasone 8 mg intravenously before chemotherapy and a 5-HT3 receptor antagonist or dexamethasone (preferred) for 2 days post-chemotherapy; and for low emetogenic chemotherapy dexamethasone 8 mg before chemotherapy and no other treatment post-chemotherapy (Kris et al, 2006; Roila et al, 2006). All patients will receive rescue antiemetics if nausea and/or vomiting is persistent and fail to respond to the antiemetic treatment (i.e. severe nausea or greater than 5 vomiting episodes), based on the experience of each clinician (as agreed guidelines for rescue antiemetics have not been developed to date).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/11/2008

Overall trial end date

31/10/2010

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

699

Participant 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)

Recruitment start date

01/11/2008

Recruitment end date

31/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Research Office
Oxford Road
Manchester
M13 9PL
United Kingdom
karen.shaw@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data