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

NCT ID: NCT06500715

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Febrile Neutropenia Sarcoma Doxorubicin Adverse Reaction Hospitalization-Associated Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participating patients will be treated with one of the following doxorubicin-based protocols, for between 4 and 6 cycles: Doxorubicin and Dacarbazine (AD regimen); Doxorubicin and Ifosfamide (AI regimen); or Doxorubicin and Cisplatin (AC regimen). Subcutaneous 6mg of pegylated G-CSF (pegfilgrastim-jmdb, Fulphila) will be administered at 24h following chemotherapy.

Allocation to study groups: Study patients will be randomly allocated (1:1) to one of the two study treatment arms: Group A, undergoing the acupuncture intervention at the 1st chemotherapy cycle; no acupuncture at the 2nd cycle; intervention at the 3rd; and so on. Group B: No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on. T
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
he treating oncologist will be blinded as to the patient's allocation and study intervention during each cycle of chemotherapy.

Study Groups

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Group A

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type 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.

Group B

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type 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.

Interventions

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Acupuncture

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.

Intervention Type DEVICE

Other Intervention Names

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Acupuncture needle; Press-Tack needle; Self-Acupressure

Eligibility Criteria

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Inclusion Criteria

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

* unwilling or unable to provide written informed consent for study participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Noah Samuels

Director, Center for Integrative Complementary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noah Samuels, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zeded Medical Center, Jerusalem, Israel

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Noah Samuels, MD

Role: CONTACT

972-26666395

Facility Contacts

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Noah Samuels, MD

Role: primary

972-26666395

References

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Lyman GH, Bohlke K, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline Summary. J Oncol Pract. 2018 Aug;14(8):495-499. doi: 10.1200/JOP.18.00283. No abstract available.

Reference Type BACKGROUND
PMID: 30096271 (View on PubMed)

Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.

Reference Type BACKGROUND
PMID: 36122322 (View on PubMed)

Shih YW, Su JY, Kung YS, Lin YH, To Anh DT, Ridwan ES, Tsai HT. Effectiveness of Acupuncture in Relieving Chemotherapy-induced Leukopenia in Patients With Breast Cancer: A Systematic Review With A Meta-Analysis and Trial Sequential Analysis. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211063884. doi: 10.1177/15347354211063884.

Reference Type BACKGROUND
PMID: 34930039 (View on PubMed)

Nian J, Sun X, Zhao W, Wang X. Efficacy and safety of acupuncture for chemotherapy-induced leukopenia: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Oct 21;101(42):e30995. doi: 10.1097/MD.0000000000030995.

Reference Type BACKGROUND
PMID: 36281119 (View on PubMed)

Li S, Huang J, Guo Y, Wang J, Lu S, Wang B, Gong Y, Qin S, Zhao S, Wang S, Liu Y, Fang Y, Guo Y, Xu Z, Ulloa L. PAC1 Receptor Mediates Electroacupuncture-Induced Neuro and Immune Protection During Cisplatin Chemotherapy. Front Immunol. 2021 Sep 6;12:714244. doi: 10.3389/fimmu.2021.714244. eCollection 2021.

Reference Type BACKGROUND
PMID: 34552585 (View on PubMed)

Samuels N, Ben-Arye E. Integrative Medicine for Cancer-Related Pain: A Narrative Review. Healthcare (Basel). 2024 Feb 4;12(3):403. doi: 10.3390/healthcare12030403.

Reference Type BACKGROUND
PMID: 38338288 (View on PubMed)

Other Identifiers

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ACP-CIFN.2024

Identifier Type: -

Identifier Source: org_study_id

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