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

NCT06500715 | Not Yet Recruiting

• 1 other identifier: ACP-CIFN.2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

febrile neutropenia; acupuncture; sarcoma; doxorubicin; hospitalization

Outcome Measures

Primary Outcomes (2)

• Incidence of chemotherapy-induced febrile neutropenia-related hospitalization

  3 weeks

• Duration of chemotherapy-induced febrile neutropenia-related hospitalization

  3 weeks

Secondary Outcomes (5)

• Relative Dose Intensity of Chemotherapy Regimen

  3 weeks

• G-CSF-related muscle and bone pain

  3 wseks

• Quality of life-related outcomes: Quantitative Assessment

  3 weeks

• Quality of life-related outcomes: Qualitative Assessment

  3 weeks

• Adverse effects of study intervention

  3 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Device: Acupuncture

Group B

ACTIVE COMPARATOR

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

Device: Acupuncture

Interventions

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.

Also known as: Acupuncture needle; Press-Tack needle; Self-Acupressure

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unwilling or unable to provide written informed consent for study participation

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (6)

• 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.

  PMID: 30096271 BACKGROUND

• 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.

  PMID: 36122322 BACKGROUND

• 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.

  PMID: 34930039 BACKGROUND

• 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.

  PMID: 36281119 BACKGROUND

• 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.

  PMID: 34552585 BACKGROUND

• 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.

  PMID: 38338288 BACKGROUND

MeSH Terms

Conditions

Febrile Neutropenia; Sarcoma; Cross Infection

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Noah Samuels, MD

  Shaare Zeded Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah Samuels, MD

CONTACT

972-26666395; noahs@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: he treating oncologist will be blinded as to the patient's allocation and study intervention during each cycle of chemotherapy.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Complementary Medicine

Model Details: 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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)