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NCT Number: NCT06500715

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

Acupuncture will be administered bilaterally on points PC6, LI 4, CV6, SP6, SP10 and ST36 on the first day of each cycle (d1), prior to administration of chemotherapy; and on d8, each session lasting between 30 to 45 minutes. Patients will continue from d1 to d8 with press-tack acupuncture needles on points PC 6, LI4, SP 6 and ST 36. On d8, patients will again undergo acupuncture, and continue with self-acupressure on the same points as the press-tack needles, until the next chemotherapy cycle.

Other names: Acupuncture needle; Press-Tack needle; Self-Acupressure

Primary outcomes

  1. Incidence of chemotherapy-induced febrile neutropenia-related hospitalization

    Time frame: 3 weeks

  2. Duration of chemotherapy-induced febrile neutropenia-related hospitalization

    Time frame: 3 weeks

Secondary outcomes

  1. Relative Dose Intensity of Chemotherapy Regimen

    Time frame: 3 weeks

    Actual vs. planned dosage and interval between cycles

  2. G-CSF-related muscle and bone pain

    Time frame: 3 wseks

    Patient-reported outcome measures

  3. Quality of life-related outcomes: Quantitative Assessment

    Time frame: 3 weeks

    Patient-reported outcome measures

  4. Quality of life-related outcomes: Qualitative Assessment

    Time frame: 3 weeks

    MYCaW narratives

  5. Adverse effects of study intervention

    Time frame: 3 weeks

    Patient medical files

Study contacts

Contact information is provided by the study sponsor or research team.

Noah Samuels, MD

CONTACT

[email protected]

972-26666395

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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