Clinical trial NCT06500715: Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Febrile Neutropenia
Sarcoma
Doxorubicin Adverse Reaction
Hospitalization-Associated Infection
Keywords: febrile neutropenia
acupuncture
sarcoma
doxorubicin
hospitalization
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of chemotherapy-induced febrile neutropenia-related hospitalization
timeFrame: 3 weeks
measure: Duration of chemotherapy-induced febrile neutropenia-related hospitalization
timeFrame: 3 weeks
Secondary outcomes:
measure: Relative Dose Intensity of Chemotherapy Regimen
timeFrame: 3 weeks
measure: G-CSF-related muscle and bone pain
timeFrame: 3 wseks
measure: Quality of life-related outcomes: Quantitative Assessment
timeFrame: 3 weeks
measure: Quality of life-related outcomes: Qualitative Assessment
timeFrame: 3 weeks
measure: Adverse effects of study intervention
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zeded Medical Center, Jerusalem, Israel
name: Noah Samuels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.