Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

Overview

This is a prospective randomized controlled trial to obtain preliminary data for the design of a future definitive efficacy study. A randomized controlled trial is needed because comparison to historical data would be biased. The investigators will use sham acupuncture as the control to account for effect from attention from and interaction with the therapist.

Full Title of Study: “Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2020

Interventions

  • Procedure: Acupuncture
    • Patients with multiple myeloma undergoing conditioning myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation. Patients will be randomized to acupuncture or sham acupuncture. Acupuncture treatment will be delivered once daily starting on Day -1 (Day -2 is the day chemotherapy starts). Acupuncture will continue for 5 days, or, when the patient’s absolute neutrophil count drops below 200/microliter or platelet count drops below 20,000/microliter, whichever is sooner. Sham acupuncture will be delivered on the same schedule. Regardless of group assignment, every patient will receive the same usual prevention and treatment regimen for nausea, vomiting, anxiety, insomnia and fatigue that other patients who are undergoing conditioning chemotherapy in preparation for HSCT will receive in the Transplant Service.
  • Procedure: Sham acupuncture
    • Patients with multiple myeloma undergoing conditioning myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation. Patients will be randomized to acupuncture or sham acupuncture. Acupuncture treatment will be delivered once daily starting on Day -1 (Day -2 is the day chemotherapy starts)Acupuncture will continue for 5 days, or, when the patient’s absolute neutrophil count drops below 200/microliter or platelet count drops below 20,000/microliter, whichever is sooner. Sham acupuncture will be delivered on the same schedule. Regardless of group assignment, every patient will receive the same usual prevention and treatment regimen for nausea, vomiting, anxiety, insomnia and fatigue that other patients who are undergoing conditioning chemotherapy in preparation for HSCT will receive in the Transplant Service.

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • Acupuncture treatment once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.
  • Sham Comparator: Sham acupuncture
    • Sham acupuncture once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.

Clinical Trial Outcome Measures

Primary Measures

  • whether acupuncture reduces common symptoms
    • Time Frame: 2 years
    • In patients undergoing chemotherapy prior to hematopoietic stem cell transplantation. The primary endpoint is the area-under-curve (AUC) for MDASI total score from Day -2 to Day 5. MDASI scores are assessed daily by having the patient fill out the questionnaire. Severity is assessed for the 13 core MDASI symptom items (pain, fatigue, nausea, disturbed sleep, distress etc..) AUC for MDASI total score from Day -2 to Day 5 will be compared between the acupuncture group and the sham acupuncture group.

Secondary Measures

  • to assess the effect size for each symptom
    • Time Frame: 2 years
    • Effect size for each symptom will be calculated descriptively. To determine whether baseline characteristics predict response to acupuncture, each will be added as an interaction term to the primary model. The following predictors will be explored: inpatient vs outpatient treatment, upfront vs. salvage transplantation, age, baseline MDASI score, pro-inflammatory cytokine levels, and use of symptom control medications (yes / no).

Participating in This Clinical Trial

Inclusion Criteria

  • Age 21 or above (those age below 21 are usually treated in the Pediatric Transplant Service)
  • Diagnosis of multiple myeloma
  • Scheduled to receive conditioning chemotherapy followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation

Exclusion Criteria

  • Absolute neutrophil count less than 200/microliter
  • Platelet count less than 20,000/microliter
  • Acupuncture treatment in the preceding 4 weeks prior to Day 1

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gary Deng, MD, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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