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

Shaare Zedek Medical Center

Status: Not yet enrolling

Conditions: Febrile Neutropenia; Sarcoma; Doxorubicin Adverse Reaction; Hospitalization-Associated Infection

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06500715

ACP-CIFN.2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Device: Acupuncture

Group B

Active Comparator group

Description:

No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on.

Treatment:

Device: Acupuncture