Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003817
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
1999-11-01
Brief Title:
Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Status:
COMPLETED
Status Verified Date:
2015-10
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 Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer
PURPOSE Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of acupressure and acustimulation as adjuncts to standard serotonin antiemetics in reducing acute nausea day of treatment and delayed nausea 1-4 days following treatment associated with cisplatin or doxorubicin based chemotherapy in cancer patients II Evaluate the efficacy of acupressure and acustimulation in reducing acute and delayed vomiting and in improving quality of life in cancer patients III Investigate the relationship between expectations for the development of chemotherapy-related nauseavomiting and its actual occurrence in cancer patients
OUTLINE This is a randomized study Patients are stratified according to chemotherapy agent and research site Patients are randomized to one of three treatment arms Arm I Patients receive standard antiemetic therapy with serotonin receptor antagonists Arm II Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acupressure wrist band an elastic band equipped with a small plastic button used to apply pressure to a specific point on the wrist continuously for 5 consecutive days except when necessary to avoid immersion in water Patients may wear the band on either wrist including alternating between wrists if desired Arm III Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acustimulation wrist band a portable transcutaneous electrical nerve stimulator TENS device continuously for 5 consecutive days except when necessary to avoid immersion in water Patients may wear the band on either wrist including alternating between wrists if desired and may adjust the intensity of stimulation for optimum effectiveness All patients complete a questionnaire concerning expectations of nausea and other side effects prior to receiving chemotherapy with cisplatin and doxorubicin Patients in arms II and III complete this measure after the wrist band is in position All patients complete a questionnaire and a 5 day diary at home concerning nausea and emesis following the first chemotherapy treatment and then complete a quality of life questionnaire on the fourth day following treatment
PROJECTED ACCRUAL A total of 700 patients will be accrued for this study over 3 years
OUTLINE This is a randomized study Patients are stratified according to chemotherapy agent and research site Patients are randomized to one of three treatment arms Arm I Patients receive standard antiemetic therapy with serotonin receptor antagonists Arm II Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acupressure wrist band an elastic band equipped with a small plastic button used to apply pressure to a specific point on the wrist continuously for 5 consecutive days except when necessary to avoid immersion in water Patients may wear the band on either wrist including alternating between wrists if desired Arm III Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acustimulation wrist band a portable transcutaneous electrical nerve stimulator TENS device continuously for 5 consecutive days except when necessary to avoid immersion in water Patients may wear the band on either wrist including alternating between wrists if desired and may adjust the intensity of stimulation for optimum effectiveness All patients complete a questionnaire concerning expectations of nausea and other side effects prior to receiving chemotherapy with cisplatin and doxorubicin Patients in arms II and III complete this measure after the wrist band is in position All patients complete a questionnaire and a 5 day diary at home concerning nausea and emesis following the first chemotherapy treatment and then complete a quality of life questionnaire on the fourth day following treatment
PROJECTED ACCRUAL A total of 700 patients will be accrued for this study over 3 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 |
|---|---|---|---|
| NCI-V99-1528 | None | None | None |
| URCC-U3997 | None | None | None |