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Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

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ClinicalTrials.gov Identifier: NCT01811862
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Acupuncture Procedure: Sham acupuncture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : December 10, 2021
Actual Study Completion Date : December 10, 2021

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811862


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Gary Deng, MD, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01811862    
Other Study ID Numbers: 13-038
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: December 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Acupuncture
Hematopoietic stem cell transplantation (HSCT)
13-038
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases