Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma

Not Applicable

Not yet recruiting

• Conditions: Febrile Neutropenia; Sarcoma; Doxorubicin Adverse Reaction; Hospitalization-Associated Infection
• Interventions: Device: Acupuncture

• Registration Number: NCT06500715
• Lead Sponsor: Shaare Zedek Medical Center

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 1:1) 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

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Start: 2026-01
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 18-65 years
• diagnosed with sarcoma of any stage
• scheduled for doxorubicin-based chemotherapy
• function ECOG status score of 0-1

Exclusion Criteria

• not fulfilling all inclusion criteria
• unwilling or unable to provide written informed consent for study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Acupuncture	No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on.
Group A	Acupuncture	Patients in Group A will undergo the acupuncture intervention at the 1st chemotherapy cycle; no acupuncture at the 2nd cycle; intervention at the 3rd; and so on.

Primary Outcome Measures

Name	Time	Method
Duration of chemotherapy-induced febrile neutropenia-related hospitalization	3 weeks
Incidence of chemotherapy-induced febrile neutropenia-related hospitalization	3 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life-related outcomes: Quantitative Assessment	3 weeks	Patient-reported outcome measures
Quality of life-related outcomes: Qualitative Assessment	3 weeks	MYCaW narratives
Relative Dose Intensity of Chemotherapy Regimen	3 weeks	Actual vs. planned dosage and interval between cycles
G-CSF-related muscle and bone pain	3 wseks	Patient-reported outcome measures
Adverse effects of study intervention	3 weeks	Patient medical files

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel