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Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study


N/A
21 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

whether acupuncture reduces common symptoms

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gary Deng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

13-038

NCT ID:

NCT01811862

Start Date:

March 2013

Completion Date:

March 2015

Related Keywords:

  • Multiple Myeloma
  • Acupuncture
  • Hematopoietic stem cell transplantation (HSCT)
  • 13-038
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, New York  10021