Acupressure and Relaxation for Nausea Control - Full Text View

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00243269

Purpose

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients’ response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

Condition	Intervention	Phase
Nausea	Behavioral: Acupressure expectancy enhancement	Phase I

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Acupressure and Relaxation for Nausea Control

Further study details as provided by University of Rochester:

Primary Outcome Measures:

1- Mean Nausea severity

Secondary Outcome Measures:

2- Health Related Quality of Life

Estimated Enrollment:	67
Study Start Date:	November 2005

Detailed Description:

This study hypothesizes that patients receiving efficacy enhancing information about the acupressure bands will expect less treatment-related nausea, which will subsequently result in less treatment-related nausea compared to patients who do not receive such information.

This study extends prior research by utilizing a randomized controlled trial in a clinical environment to examine the efficacy of an intervention that is specifically designed to reduce patients’ response expectancies concerning nausea development from cancer treatments, and, thereby, reduce nausea.

The objectives of this study are as follow:

To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management will result in reduced chemotherapy-induced nausea.
To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management will result in increased health-related quality of life (HRQL) in patients receiving emetogenic chemotherapy.

To provide preliminary data on whether a two-tiered strategy to increase patients’ expectancies for nausea prevention and/or management is more effective than a single-tiered strategy in reducing chemotherapy- induced nausea.

The study contains the following arms:

Arm 1 = control handout and control tape.
Arm 2 = active handout and control tape.
Arm 3 = control handout and active tape.
Arm 4 = active handout and active tape.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a diagnosis of breast cancer.
Be scheduled to receive a chemotherapy treatment containing doxorubicin (any dose) without concurrent radiotherapy or interferon. (Note: Chemotherapy agents in addition to doxorubicin may be given.)
Have no clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
Be 18 years of age or older.
Be chemotherapy naïve.
Be a female.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243269

Contacts

Contact: Leslie Gillies

585-275-0690

leslie_gillies@urmc.rochester.edu

Locations

United States, New York
University of Rochester James P. Wilmot Cancer Center	Recruiting
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Joseph A Roscoe, PhD

University of Rochester

More Information

No publications provided

Study ID Numbers:	U2905
Study First Received:	October 19, 2005
Last Updated:	October 13, 2006
ClinicalTrials.gov Identifier:	NCT00243269 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Arm 1 = control handout and control tape
Arm 2 = active handout and control tape
Arm 3 = control handout and active tape
Arm 4 = active handout and active tape)

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Nausea

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on May 07, 2009