Trial record 8 of 9 for:
Cancer | Open Studies | Exclude Unknown | NCCAM
Alternative Approaches for Nausea Control
This study is currently recruiting participants.
Verified May 2013 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01695993
First received: September 26, 2012
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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: Neutral handout; Arm 2: Neutral handout + control relaxation MP3 + acupressure bands; Arm 3: Expectancy-enhancing handout + expectancy-enhancing relaxation MP3 + acupressure bands.
Hypothesis: Acupressure bands with expectancy-enhancing supplementary material will be more effective in controlling chemotherapy-induced nausea than acupressure bands with neutral supplementary material.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea |
Device: Acupressure bands Other: Expectancy neutral handout Behavioral: Expectancy neutral MP3 Other: Expectancy enhancing handout Behavioral: Expectancy enhancing MP3 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Alternative Approaches for Nausea Control |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- patient report nausea diary [ Time Frame: five days ] [ Designated as safety issue: No ]Nausea and emesis 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." Vomiting episodes will be recorded for the same time intervals.
| Estimated Enrollment: | 216 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Arm 1
Patients will receive only an expectancy neutral thank-you note that has no mention of acupressure bands.
|
|
|
Arm 2
Patients will receive the expectancy neutral handout, the expectancy neutral MP3, and acupressure bands.
|
Device: Acupressure bands
Bilateral acupressure wrist bands (Sea-Band International, England), given to patients in trial Arms 2 and 3, are widely available and inexpensive (under $6.00 a pair).
Other: Expectancy neutral handout
The expectancy neutral handout given to patients will simply thank patients for participating in the study and includes a piece of paper that says, "Use the acupressure bands in addition to your regular medication."
Behavioral: Expectancy neutral MP3
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.
|
|
Experimental: Arm 3
Patients will receive the expectancy enhancing handout, the expectancy enhancing MP3, and acupressure bands.
|
Device: Acupressure bands
Bilateral acupressure wrist bands (Sea-Band International, England), given to patients in trial Arms 2 and 3, are widely available and inexpensive (under $6.00 a pair).
Other: Expectancy enhancing handout
There are two parts of the expectancy enhancing handout. Part 1 is a handout that provides evidence that the bands may be helpful for reducing nausea. Part 2 is a prescription signed by a medical oncologist and has the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea."
Behavioral: Expectancy enhancing MP3
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. The MP3 (for subjects randomized to Arm 3) has additional language inserted concerning efficacy of the acupressure bands and control of 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: Neutral handout; Arm 2: Neutral handout + control relaxation MP3 + acupressure bands; Arm 3: Expectancy-enhancing handout + expectancy-enhancing relaxation MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with expectancy-enhancing materials will be more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral materials.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
- Be receiving concurrent radiotherapy or interferon.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695993
Contacts
| Contact: Jenine Hoefler, M.S. | 585.276.3559 | Jenine_Hoefler@URMC.Rochester.edu |
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Mary Lynne Tarquini, RN, BSN, CCRP Tarquini, RN, BSN, C 716-845-3008 cab21@healthresearch.org | |
| Contact: Roswell Park 877-275-7724 ASKRPCI@RoswellPark.org | |
| Principal Investigator: Tracey O'Connor, M.D. | |
| Hematology-Oncology Associates of Central New York | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Contact: Coleen A Dillenbeck, MA, CCRC 315-472-7504 ext 1360 cdillenbeck@hoacny.com | |
| Principal Investigator: Jeffrey J. Kirshner, M.D. | |
| University of Rochester James P. Wilmot Cancer Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jenine Hoefler, M.S. 585-276-3559 Jenine_Hoefler@URMC.Rochester.edu | |
| Principal Investigator: Joseph A Roscoe, Ph.D. | |
| Rochester General Hospital's Lipson Cancer and Blood Center | Recruiting |
| Rochester, New York, United States, 14621 | |
| Contact: Caroline Andrews, MBA, CCRC 585-922-4040 Caroline.Andrews@rochestergeneral.org | |
| Principal Investigator: Peter Bushunow, M.D. | |
Sponsors and Collaborators
University of Rochester
Investigators
| Principal Investigator: | Joseph A Roscoe, Ph.D. | University of Rochester |
More Information
No publications provided
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01695993 History of Changes |
| Other Study ID Numbers: | UCCS1202, R01AT007474-01A1 |
| Study First Received: | September 26, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board |
Keywords provided by University of Rochester:
|
Nausea Quality of life Chemotherapy Expectancy |
Additional relevant MeSH terms:
|
Nausea Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013