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| [ Print-friendly version ] |
| The effectiveness and cost effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea |
| ISRCTN | ISRCTN87604299 |
| ClinicalTrials.gov identifier | |
| Public title | The effectiveness and cost effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea |
| Scientific title | |
| Acronym | CART |
| Serial number at source | N/A |
| 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. |
| Ethics approval | Approved by Nottingham 1 Multicentre Research Ethics Committee |
| Study design | Multicentre, randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chemotherapy-related acute and delayed nausea |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 31/08/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 699 |
| 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, 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 >5 vomiting episodes), based on the experience of each clinician (as agreed guidelines for rescue antiemetics have not been developed to date). |
| Primary outcome measure(s) | Nausea experience |
| Secondary outcome measure(s) |
1. Vomiting experience
2. Nausea & Vomiting occurrence 3. Quality of Life 4. Costs |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Alex Molassiotis |
| Address |
School of Nursing
Midwifery & Social Work University Place |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| alex.molassiotis@manchester.ac.uk | |
| Sponsor | University of Manchester (UK) |
| Address |
Research Office
Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| karen.shaw@manchester.ac.uk | |
| Date applied | 21/04/2008 |
| Last edited | 17/07/2008 |
| Date ISRCTN assigned | 03/06/2008 |
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