Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT06602167
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
Sponsor:
Affiliated Hospital of Qinghai University
Organization:
Study Overview
Official Title:
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-12
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:
This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.
Detailed Description:
This study is a parallel-group, blinded (blinding applies to participants, evaluators, investigators, and statisticians) randomized controlled trial designed to explore the preventive effect of electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment on HFS in patients with malignant tumors receiving oral capecitabine and to improve the quality of life for patients during treatment. Participants are randomly assigned to one of two groups: a true electroacupuncture combined with true self-administered acupressure group, or a sham electroacupuncture combined with sham self-administered acupressure group. The true electroacupuncture combined with true self-administered acupressure group receives true electroacupuncture combined with true self-administered acupressure plus doctor-prescribed treatment(oral administration of celecoxib, external application of diclofenac, and other skin protectants). The sham electroacupuncture combined with sham self-administered acupressure group receives sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment. HFS will be assessed following the initiation of capecitabine treatment, with records kept of the capecitabine dosage, the severity of HFS, onset time, and duration of symptoms. In addition, the HFS-14 questionnaire was used to assess the condition of patients at each cycle.
Study Oversight
Has Oversight DMC:
True
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?: