NauseaPhase 1/2NCT00243269
Acupressure and Relaxation for Nausea Control
A Phase 1/2 study testing Acupressure expectancy enhancement in people with Nausea, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nausea
- What is being tested?
- Acupressure expectancy enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642
About this study
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.
Read more
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.
Read the 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:
- Control handout and control tape.
- Active handout and control tape.
- Control handout and active tape.
- Active handout and active tape.
- Conditions
- Nausea
- Being tested
- Acupressure expectancy enhancement
- Keywords
- nausea, acupressure bands, relaxation
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure expectancy enhancementBehavioural
Also called 1 - Control handout and control tape, 2 - Active handout and control tape, 3 - Control handout and active tape, 4 - Active handout and active tape
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Expectancy neutral handout and expectancy neutral tape Receives: Behavioral: Acupressure expectancy enhancement |
| 2 | Experimental | Expectancy enhancing handout and expectancy neutral tape Receives: Behavioral: Acupressure expectancy enhancement |
| 3 | Experimental | Expectancy neutral handout and expectancy enhancing tape Receives: Behavioral: Acupressure expectancy enhancement |
| 4 | Experimental | Expectancy enhancing handout and expectancy enhancing tape Receives: Behavioral: Acupressure expectancy enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-day Nausea Diary
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.
Measured: Five days
Secondary outcomes (1)
Health Related Quality of Life
Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale - General (FACT-G). The FACT-G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Roscoe, University of Rochester
- Investigators
- Joseph A Roscoe, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243269
- Sponsor's protocol ID
- U2905
- Status last verified
- Mar 2010
- First submitted
- 19 Oct 2005
- Last updated
- 18 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Roscoe JA, O'Neill M, Jean-Pierre P, Heckler CE, Kaptchuk TJ, Bushunow P, Shayne M, Huston A, Qazi R, Smith B. An exploratory study on the effects of an expectancy manipulation on chemotherapy-related nausea. J Pain Symptom Manage. 2010 Sep;40(3):379-90. doi: 10.1016/j.jpainsymman.2009.12.024. Epub 2010 Jun 25.
PubMed 20579837
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure and Relaxation for Nausea Control
- ClinicalTrials.gov ID
- NCT00243269
- Acronym / sponsor ID
- U2905
- Conditions
- Nausea
- Keywords
- nausea, acupressure bands, relaxation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Posted 21 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Control handout and control tape.
- Active handout and control tape.
- Control handout and active tape.
- Active handout and active tape.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Behavioral: Acupressure expectancy enhancementExpectancy neutral handout and expectancy neutral tape |
| 2 | Experimental | Behavioral: Acupressure expectancy enhancementExpectancy enhancing handout and expectancy neutral tape |
| 3 | Experimental | Behavioral: Acupressure expectancy enhancementExpectancy neutral handout and expectancy enhancing tape |
| 4 | Experimental | Behavioral: Acupressure expectancy enhancementExpectancy enhancing handout and expectancy enhancing tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure expectancy enhancementAlso: 1 - Control handout and control tape, 2 - Active handout and control tape, 3 - Control handout and active tape, 4 - Active handout and active tapeThis 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. | Behavioural | 1, 2, 3, 4 |
Primary outcome
Five-day Nausea Diary
Time frame: Five days
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.
1 secondary outcome
Health Related Quality of Life
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20579837Roscoe JA, O'Neill M, Jean-Pierre P, Heckler CE, Kaptchuk TJ, Bushunow P, Shayne M, Huston A, Qazi R, Smith B. An exploratory study on the effects of an expectancy manipulation on chemotherapy-related nausea. J Pain Symptom Manage. 2010 Sep;40(3):379-90. doi: 10.1016/j.jpainsymman.2009.12.024. Epub 2010 Jun 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Roscoe, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupressure expectancy enhancement in people with Nausea, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-day Nausea Diary (time frame: Five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.