NauseaNCT01695993
Alternative Approaches for Nausea Control
A study testing Acupressure bands, Expectancy-neutral handout and Expectancy-neutral MP3 in people with Nausea, run by University of Rochester at 4 sites in United States.
Trial summary
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing… 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 bands, Expectancy-neutral handout and Expectancy-neutral MP3
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to 16 May 2017
- Phase
- Interventional
- 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
- Be female.
- Have a diagnosis of breast cancer, any stage.
- Be chemotherapy naïve and about to begin her first course of chemotherapy.
- Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
- Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
- Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
Show all 12Show fewer
- Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \& 3.
- Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \& 3.
- Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
- Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."
- Be able to read English (since the assessment materials are in printed format).
- Be 18 years of age or older and give written informed consent.
Who cannot join
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
- Be receiving concurrent radiotherapy or interferon.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Rochester General Hospital's Lipson Cancer and Blood Center
Rochester, New York, 14621
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642
About this study
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.
Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Read the detailed description
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.
- Conditions
- Nausea
- Being tested
- Acupressure bands, Expectancy-neutral handout, Expectancy-neutral MP3, Expectancy-enhancing handout, Expectancy-enhancing MP3
- Keywords
- Nausea, Quality of life, Chemotherapy, Expectancy
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure bandsDevice
Bilateral acupressure wrist bands
Expectancy-neutral handoutOther
The expectancy neutral handout has neutral information regarding the acupressure bands
Expectancy-neutral MP3Behavioural
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
Expectancy-enhancing handoutOther
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
Expectancy-enhancing MP3Behavioural
Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard Care Only | No intervention | Patients will receive standard care only |
| Arm 2 - Expectancy-neutral Arm | Other | Patients receive:
1. Expectancy-neutral handout
2. Expectancy-neutral MP3
3. Acupressure bands Receives: Device: Acupressure bands; Other: Expectancy-neutral handout; Behavioral: Expectancy-neutral MP3 |
| Arm 3 - Expectancy-enhancing Arm | Experimental | Patients receive:
1. Expectancy-enhancing handout
2. Expectancy-enhancing MP3
3. Acupressure bands Receives: Device: Acupressure bands; Other: Expectancy-enhancing handout; Behavioral: Expectancy-enhancing MP3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Report Nausea Diary
Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is 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 outcome variable for the primary analysis was greatest reported nausea from the five day period.
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startNov 2012
- Primary completion16 May 2017
- Study completion16 May 2017
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Joseph Roscoe, University of Rochester
- Investigators
- Joseph A Roscoe, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695993
- Sponsor's protocol ID
- UCCS1202
- Other IDs
- R01AT007474-01A1
- Status last verified
- May 2018
- First submitted
- 26 Sep 2012
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Approaches for Nausea Control
- ClinicalTrials.gov ID
- NCT01695993
- Acronym / sponsor ID
- UCCS1202
- Conditions
- Nausea
- Keywords
- Nausea, Quality of life, Chemotherapy, Expectancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2012 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 25 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.
Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Detailed description
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard Care Only | No intervention | –Patients will receive standard care only |
| Arm 2 - Expectancy-neutral Arm | Other | Device: Acupressure bands, Other: Expectancy-neutral handout, Behavioral: Expectancy-neutral MP3Patients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands |
| Arm 3 - Expectancy-enhancing Arm | Experimental | Device: Acupressure bands, Other: Expectancy-enhancing handout, Behavioral: Expectancy-enhancing MP3Patients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be female.
- Have a diagnosis of breast cancer, any stage.
- Be chemotherapy naïve and about to begin her first course of chemotherapy.
- Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
- Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
Key exclusion criteria (2 listed)
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
- Be receiving concurrent radiotherapy or interferon.
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 bandsBilateral acupressure wrist bands | Device | Arm 2 - Expectancy-neutral Arm, Arm 3 - Expectancy-enhancing Arm |
| Expectancy-neutral handoutThe expectancy neutral handout has neutral information regarding the acupressure bands | Other | Arm 2 - Expectancy-neutral Arm |
| Expectancy-neutral MP3Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. | Behavioural | Arm 2 - Expectancy-neutral Arm |
| Expectancy-enhancing handoutThe expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands | Other | Arm 3 - Expectancy-enhancing Arm |
| Expectancy-enhancing MP3Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands. | Behavioural | Arm 3 - Expectancy-enhancing Arm |
Primary outcome
Patient Report Nausea Diary
Time frame: five days
Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is 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 outcome variable for the primary analysis was greatest reported nausea from the five day period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure bands, Expectancy-neutral handout and Expectancy-neutral MP3 in people with Nausea, run by University of Rochester at 4 sites 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 12 inclusion and 2 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2018). 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?
Patient Report 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?
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 26 Jun 2018.