Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments acupuncture, sham acupuncture
Sponsor Memorial Sloan Kettering Cancer Center
Start date March 2013
End date March 2017
Trial size 63 participants
Trial identifier NCT01811862, 13-038

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Acupuncture treatment once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.
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 once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.
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.

Primary Outcomes

Measure
whether acupuncture reduces common symptoms
time frame: 2 years

Secondary Outcomes

Measure
to assess the effect size for each symptom
time frame: 2 years

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study
Principal investigator Gary Deng, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.