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Acupressure and Relaxation for Nausea Control


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Nausea

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Trial Information

Acupressure and Relaxation for Nausea Control


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:

1. 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.

2. 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:

1. Control handout and control tape.

2. Active handout and control tape.

3. Control handout and active tape.

4. Active handout and active tape.


Inclusion Criteria:



1) Have a diagnosis of breast cancer. 2) 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.) 3) Be 18 years of age or
older. 3) Be chemotherapy naïve. 5) Be a female.

Exclusion Criteria:

1) Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain
metastases, as determined by their treating oncologist.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Five-day Nausea Diary

Outcome Description:

Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The description "Moderately nauseated" was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods.

Outcome Time Frame:

Five days

Safety Issue:

No

Principal Investigator

Joseph A Roscoe, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

U2905

NCT ID:

NCT00243269

Start Date:

November 2005

Completion Date:

January 2010

Related Keywords:

  • Nausea
  • nausea, acupressure bands, relaxation
  • Nausea

Name

Location

University of Rochester James P. Wilmot Cancer CenterRochester, New York  14642