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Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01811862
First received: March 13, 2013
Last updated: July 16, 2014
Last verified: July 2014

March 13, 2013
July 16, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
whether acupuncture reduces common symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01811862 on ClinicalTrials.gov Archive Site
to assess the effect size for each symptom [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients
Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Multiple Myeloma
  • 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.
  • 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.
    Intervention: Procedure: Acupuncture
  • 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.
    Intervention: Procedure: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Gary Deng, MD PhD 646-888-0841
Contact: Sergio Giralt, MD 212-639-6009
United States
 
NCT01811862
13-038
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Gary Deng, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP