Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

Conditions

Multiple Myeloma

Keywords

Acupuncture, Hematopoietic stem cell transplantation (HSCT), 13-038

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.

Sarah El Iskandarani, Lingyun Sun, Susan Qing Li, M. Glória Pereira, Sergio Giralt et al. (6 authors)

Acupuncture in Medicine2023-07-063 citations

10.1177/09645284231181403

Acupuncture As a Potential Opioid-Sparing Pain Management Intervention for Patients Undergoing Cancer Treatment

Gary Deng

Medical Acupuncture2020-12-015 citations

10.1089/acu.2020.1494

Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial.

Deng G, Giralt S, Chung DJ, Landau H, Siman J, Search B, Coleton M, Vertosick E, Shapiro N, Chien C, Wang XS, Cassileth B, Mao JJ.

2017-09-1721 citations

10.1007/s00520-017-3881-7

Acupuncture for symptom reduction in myeloma patients undergoing hematopoietic stem cell transplantation: A randomized, sham-controlled trial.

Gary Deng, Sergio Giralt, David J. Chung, Heather Landau, Jonathan Siman et al. (13 authors)

Journal of Clinical Oncology2017-05-201 citations

10.1200/jco.2017.35.15_suppl.8021

Interventions

PROCEDUREAcupuncture

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.

PROCEDURESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed