Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

NCT ID: NCT01811862

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2021-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acupuncture Hematopoietic stem cell transplantation (HSCT) 13-038

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture

Acupuncture treatment once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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 acupuncture

Sham acupuncture once daily inpatient for 5 consecutive days starting at on the day after chemotherapy plus usual pre- and post-transplantation care.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary Deng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

El Iskandarani S, Sun L, Li SQ, Pereira G, Giralt S, Deng G. Acupuncture improves certain aspects of sleep in hematopoietic stem cell transplantation patients: a secondary analysis of a randomized controlled trial. Acupunct Med. 2023 Dec;41(6):319-326. doi: 10.1177/09645284231181403. Epub 2023 Jul 6.

Reference Type DERIVED
PMID: 37409464 (View on PubMed)

Deng G. Acupuncture As a Potential Opioid-Sparing Pain Management Intervention for Patients Undergoing Cancer Treatment. Med Acupunct. 2020 Dec 1;32(6):394-395. doi: 10.1089/acu.2020.1494. Epub 2020 Dec 16.

Reference Type DERIVED
PMID: 33362896 (View on PubMed)

Deng G, Giralt S, Chung DJ, Landau H, Siman J, Li QS, Lapen K, Mao JJ. Reduction of Opioid Use by Acupuncture in Patients Undergoing Hematopoietic Stem Cell Transplantation: Secondary Analysis of a Randomized, Sham-Controlled Trial. Pain Med. 2020 Mar 1;21(3):636-642. doi: 10.1093/pm/pnz190.

Reference Type DERIVED
PMID: 31498394 (View on PubMed)

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. Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial. Support Care Cancer. 2018 Feb;26(2):657-665. doi: 10.1007/s00520-017-3881-7. Epub 2017 Sep 17.

Reference Type DERIVED
PMID: 28920142 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-038

Identifier Type: -

Identifier Source: org_study_id