Completed

Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study

What is being tested

Acupuncture

+ Sham acupuncture

Procedure

Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 21 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center

Last updated: December 14, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01811862

Principal SponsorMemorial Sloan Kettering Cancer Center

Last updated: December 14, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellMultiple Myeloma

Criteria

3 inclusion criteria required to participate

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

3 exclusion criteria prevent from participating

Absolute neutrophil count less than 200/microliter

Acupuncture treatment in the preceding 4 weeks prior to Day 1

Platelet count less than 20,000/microliter

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Sham

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Memorial Sloan Kettering Cancer Center

New York, United StatesOpen Memorial Sloan Kettering Cancer Center in Google Maps

CompletedOne Study Center