Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500715
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma a Randomized Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Chemotherapy-induced febrile neutropenia CIFN is a dangerous complication of many chemotherapy drugs with current treatment with granulocyte colony-stimulating factors G-CSFs accompanied by adverse effects primarily muscle and bone pain Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk 40 for developing CIFN Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy though its effect on the incidence of CIFN-related hospitalization has yet to be examined In the proposed study patients with sarcoma will be randomly allocated in a ratio of 11 to Group A receiving acupuncture during cycles 1 3 and 5 or Group B during cycles 2 4 and 6 with the study oncologist blinded regarding allocation Acupuncture will be administered on the first day d1 and the 8th day d8 of the chemotherapy cycles with press-tack needles on d1 to d8 and patients will be taught to self-treat with acupressure from d8 to the next cycle The incidence and duration of hospitalization due to CIFN will be examined as will adherence to the chemotherapy regimen G-CSF-related pain and other outcomes using 3 quality-of-life-focused questionnaires The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN such as those used in the treatment of sarcoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None