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Trial Title:
Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma
NCT ID:
NCT06500715
Condition:
Febrile Neutropenia
Sarcoma
Doxorubicin Adverse Reaction
Hospitalization-Associated Infection
Conditions: Official terms:
Sarcoma
Neutropenia
Febrile Neutropenia
Hyperthermia
Fever
Conditions: Keywords:
febrile neutropenia
acupuncture
sarcoma
doxorubicin
hospitalization
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
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
Masking:
Single (Care Provider)
Masking description:
he treating oncologist will be blinded as to the patient's allocation and study
intervention during each cycle of chemotherapy.
Intervention:
Intervention type:
Device
Intervention name:
Acupuncture
Description:
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.
Arm group label:
Group A
Arm group label:
Group B
Other name:
Acupuncture needle; Press-Tack needle; Self-Acupressure
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
91031
Country:
Israel
Contact:
Last name:
Noah Samuels, MD
Phone:
972-26666395
Email:
noahs@szmc.org.il
Start date:
January 2025
Completion date:
June 2027
Lead sponsor:
Agency:
Shaare Zedek Medical Center
Agency class:
Other
Source:
Shaare Zedek Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500715
