- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01695993
Alternative Approaches for Nausea Control
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
East Syracuse, New York, Förenta staterna, 13057
- Hematology-Oncology Associates of Central New York
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester James P. Wilmot Cancer Center
-
Rochester, New York, Förenta staterna, 14621
- Rochester General Hospital's Lipson Cancer and Blood Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Arm 1 - Standard Care Only
Patients will receive standard care only
|
|
Övrig: Arm 2 - Expectancy-neutral Arm
Patients receive:
|
Bilateral acupressure wrist bands
The expectancy neutral handout has neutral information regarding the acupressure bands
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.
|
Experimentell: Arm 3 - Expectancy-enhancing Arm
Patients receive:
|
Bilateral acupressure wrist bands
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient Report Nausea Diary
Tidsram: 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.
|
five days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Joseph A Roscoe, Ph.D., University of Rochester
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UCCS1202
- R01AT007474-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Acupressure bands
-
Eastern Mediterranean UniversityHar inte rekryterat ännuNyfödd; VitalitetCypern
-
NYU Langone HealthHope FoundationAvslutad
-
National Taiwan University HospitalChina Medical University, TaiwanAvslutad
-
Medical University of South CarolinaAvslutad
-
University Medical Center GroningenAvslutadHjärtkateteriseringNederländerna
-
The University of Hong KongOkänd
-
University Hospital, Basel, SwitzerlandAvslutadFunktionellt illamåendeSchweiz
-
Changhua Christian HospitalAvslutadStroke | Cancer | Kroniska njursjukdomar | OsteoporosTaiwan
-
Centre Hospitalier Régional Metz-ThionvilleHar inte rekryterat ännu
-
Gabi SmartCareAvslutadSömnstörd andning | Syreavsättningar i blodetBelgien