Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy

NCT00978185 | Completed Phase 3

• 3 other identifiers: CDR0000649812UM-ACMCNEU-20971
• Study Type: interventional
• Target: 699
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is not yet known whether acupressure wristbands are more effective than standard care in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well they work compared with standard care in controlling nausea caused by chemotherapy.

Conditions

Anxiety Disorder; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting; anxiety disorder; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of nausea as assessed by the Rhodes Index of Nausea & Vomiting before and after chemotherapy

Secondary Outcomes (6)

• Incidence and extent of acute and delayed nausea and vomiting by the MASCC Antiemesis Tool at day 10 of each course

• Quality of life as assessed by FACT-G at baseline and at day 10 of each course

• Anxiety as assessed by the Hospital Anxiety & Depression Scale at baseline

• Expectation for nausea and vomiting as assessed by the Patient Expectations of Nausea/Vomiting after each chemotherapy course

• Measure of blindness (to intervention vs sham) assessed after chemotherapy

Interventions

medical chart review OTHER

questionnaire administration OTHER

acupressure therapy PROCEDURE

quality-of-life assessment PROCEDURE

sham intervention PROCEDURE

standard follow-up care PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of any cancer * Scheduled to receive their first chemotherapy course * Scheduled to receive highly, moderately, or low-emetogenic chemotherapy * Scheduled to receive a chemotherapy regimen given as a single administration at the beginning of the course repeated in 3-week courses * Currently receiving adjuvant chemotherapy as outpatient * Acupressure wristband-naïve (in terms of never having tried such a wristband; may have seen or heard about such wristbands) PATIENT CHARACTERISTICS: * Able to perform self care (i.e., no inability to use wristbands appropriately or mental incapacity preventing continuous and optimal use of wristbands) as judged by the investigators * No liver disease * No metabolic risk factors for nausea (i.e., electrolyte imbalances causing nausea/vomiting) * No mechanical risk factors for nausea (i.e., intestinal obstruction) * No nausea and/or vomiting due to use of opioids * No lymphedematous arms * No chronic alcohol use PRIOR CONCURRENT THERAPY: * No concurrent radiotherapy * No concurrent chemotherapy regimens as inpatients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, England, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Nausea; Vomiting

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alex Molassiotis, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2009-09

Locations

GB (1)