Phase 2
N=83
Acupressure and Relaxation for Nausea Control
Nausea
Bottom Line
View on ClinicalTrials.gov: NCT00243269 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Five-day Nausea Diary — 2.0; 2.1; 2.1; 1.9 Units on scale — p=0.932
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acupressure expectancy enhancement (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five-day Nausea Diary |
2.0; 2.1; 2.1; 1.9 | 0.932 |
| SECONDARY Health Related Quality of Life |
75.2; 74.6; 70.9; 75.9 | 0.84 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
Data sourced from ClinicalTrials.gov (NCT00243269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.