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
| Registry | NCT06500715 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: single, prevention |
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| Enrollment | 60 (Estimated) |
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| Sponsor | Shaare Zedek Medical Center (Other) |
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| Conditions | Febrile Neutropenia, Sarcoma, Doxorubicin Adverse Reaction, Hospitalization-Associated Infection |
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| Interventions | Acupuncture (Device) |
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| Dates | start 2026-12-01 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2024-07-15, last updated 2026-04-29 |
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| Locations | 1 site in Israel |
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Related Papers Related Patents Related Grants Related Experts
All trials for Febrile Neutropenia All trials for Sarcoma All trials of Acupuncture
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Group A | Active comparator | Device: 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. |
| Group B | Active comparator | Device: Acupuncture | No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on. |
- Acupuncture (Device), also known as Acupuncture needle; Press-Tack needle; Self-Acupressure: 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.
+Outcome measures
Primary outcomes
- Incidence of chemotherapy-induced febrile neutropenia-related hospitalization [3 weeks]
- Duration of chemotherapy-induced febrile neutropenia-related hospitalization [3 weeks]
Secondary outcomes
- 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
- Quality of life-related outcomes: Quantitative Assessment [3 weeks]: Patient-reported outcome measures
- Quality of life-related outcomes: Qualitative Assessment [3 weeks]: MYCaW narratives
- Adverse effects of study intervention [3 weeks]: Patient medical files
+Eligibility
Sex: All, ages: 18 Years to 65 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Shaare Zedek Medical Center | Jerusalem | Israel | |
+Publications
- 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
- 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
- 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
- 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
- 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
- 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
+Investigators
- Noah Samuels, MD, Principal investigator, Shaare Zeded Medical Center, Jerusalem, Israel