Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Procedure: Acupuncture; Procedure: Sham acupuncture

• Registration Number: NCT01811862
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Status Verified: 2021-12
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	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 acupuncture	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.

Primary Outcome Measures

Name	Time	Method
whether acupuncture reduces common symptoms	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

Name	Time	Method
to assess the effect size for each symptom	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).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States