NCT01811862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable multiple-myeloma

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

8.8 years

First QC Date

March 13, 2013

Last Update Submit

December 13, 2021

Conditions

Multiple Myeloma

Keywords

AcupunctureHematopoietic stem cell transplantation (HSCT)13-038

Outcome Measures

Primary Outcomes (1)

  • whether acupuncture reduces common symptoms

    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.

    2 years

Secondary Outcomes (1)

  • to assess the effect size for each symptom

    2 years

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Procedure: Acupuncture

Sham acupuncture

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.

Procedure: Sham acupuncture

Interventions

AcupuncturePROCEDURE

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.

Acupuncture
Sham acupuncturePROCEDURE

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (4)

  • 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.

    PMID: 37409464DERIVED

  • 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.

    PMID: 33362896DERIVED

  • 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.

    PMID: 31498394DERIVED

  • 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.

    PMID: 28920142DERIVED

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Gary Deng, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

March 1, 2013

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Locations

US(1)