Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05528263
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2022-08-29
Brief Title:
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture PACT Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture A Randomized Controlled Trial PACT Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PACT
Brief Summary:
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy CIPN a side effect of some kinds of chemotherapy that causes pain numbness tingling swelling or muscle weakness mostly in the hands or feet
This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer
The names of the study activities involved in this study areis
Acupuncture treatments for participants in the Acupuncture Group
Nature videos with a relaxation exercise for participants in the Relaxation Exercise Group
The Comprehensive and Integrative Medicine Institute CIMI of South Korea is supporting this research study by providing funding
This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer
The names of the study activities involved in this study areis
Acupuncture treatments for participants in the Acupuncture Group
Nature videos with a relaxation exercise for participants in the Relaxation Exercise Group
The Comprehensive and Integrative Medicine Institute CIMI of South Korea is supporting this research study by providing funding
Detailed Description:
This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups
The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment
The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise Both programs will last 12 weeks
Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program so participants be on this research study for up to 24 weeks 6 months
It is expected that about 80 people will take part in this research study
The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment
The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise Both programs will last 12 weeks
Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program so participants be on this research study for up to 24 weeks 6 months
It is expected that about 80 people will take part in this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None