Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046865
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2002-10-03
Brief Title:
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Treatment of Chemotherapy-Induced Nausea With Acupressure A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer
Detailed Description:
OBJECTIVES
Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone
Compare the quality of life presence of anxiety and functional status of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to chemotherapy regimen doxorubicin and cyclophosphamide vs doxorubicin cyclophosphamide and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil epirubicin and cyclophosphamide and treatment setting Patients are randomized to 1 of 3 arms
Arm I Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes
Arm II Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy Acupressure is applied as in arm I except at a non-specific site
Arm III Patients receive usual nausea care during the second or third course of chemotherapy
All patients complete a daily log during the second or third course of chemotherapy Quality of life is assessed at baseline and after the last treatment
PROJECTED ACCRUAL A total of 244 patients will be accrued for this study within 2 years
Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone
Compare the quality of life presence of anxiety and functional status of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to chemotherapy regimen doxorubicin and cyclophosphamide vs doxorubicin cyclophosphamide and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil epirubicin and cyclophosphamide and treatment setting Patients are randomized to 1 of 3 arms
Arm I Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes
Arm II Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy Acupressure is applied as in arm I except at a non-specific site
Arm III Patients receive usual nausea care during the second or third course of chemotherapy
All patients complete a daily log during the second or third course of chemotherapy Quality of life is assessed at baseline and after the last treatment
PROJECTED ACCRUAL A total of 244 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NUR01-396 | OTHER | UT MD Andrerson Cancer Center | None |
| MDA-NUR01-396 | None | None | None |
| NCI-0109 | None | None | None |
| NCI-P02-0230 | None | None | None |
| NCI-5950 | None | None | None |