Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05949307
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-18
First Post:
2023-06-28
Brief Title:
The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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 or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life At present there is no better treatment for this side effect of chemotherapy or target therapy In severe cases it is necessary to reduce the dose of chemotherapy or target therapy which may affect the progress and effect of chemotherapy In recent years acupuncture has been widely used for many side effects of chemotherapy such as numbness of hands and feet gastrointestinal discomfort and dizziness There have been many studies have proved to be effective but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients Therefore the investigators expect to evaluate the efficacy of acupuncture and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future
Detailed Description:
The investigators design a single-center sham-controlled assessor- and subject- blind randomized clinical trial 60 subjects will be equally and randomly divided into an acupuncture group laser acupuncture and sham-laser acupuncture groups in the 6-week trial Each subject receives acupuncture laser acupuncture or sham-laser acupuncture three times a week for three consecutive weeks depending on their group with a total of 9 times interventions Outcome measures include Common adverse events evaluation standard version 50 CTCAE and Visual Analogue Scale VAS Dermatology Life Quality Index DLQI and assessment of cancer patients quality of life questionnaire EORTC QLQ-C30 ANSWatch and Thermal Image Camera are also used to assess those subjects Those outcome measures will be conducted at baseline the 3rd and the 6th week after the interventions
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