NCT04459416 · REGISTRY CONDITION SEARCH

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2025-10-20

The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

the Number of Patients Using Opioids at a Given Time

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outcome · POSTED

the Number of Patients Using Opioids at a Given Time

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outcome · POSTED

Symptom Burden

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outcome · POSTED

Symptom Burden

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outcome · POSTED

Symptom Burden

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * age 18 or older * pathological diagnosis of MM, HD or NHL * scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days) * not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed) Exclusion Criteria: * absolute neutrophil count (ANC) of \<500/μl, platelet count of \<20,000/ μl or INR \>2.0 * acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture) * unable to provide informed consent
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief.
intervention Names
Other: Acupuncture
Drug: opioid
Other: Assessments
label
Usual Care plus Acupuncture
type
EXPERIMENTAL
description
Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care.
intervention Names
Drug: opioid
Other: Assessments
label
Usual Care
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Usual Care plus Acupuncture
description
Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice.
name
Acupuncture
type
OTHER
arm Group Labels
Usual Care
Usual Care plus Acupuncture
description
All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.
name
opioid
type
DRUG
arm Group Labels
Usual Care
Usual Care plus Acupuncture
description
Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
name
Assessments
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

This is a multicenter, two-arm randomized controlled trial. Randomization will be stratified by study site, primary cancer diagnosis (MM versus HD versus NHL) and transplantation setting (inpatient versus outpatient) to ensure these characteristics are comparably distributed between the two study arms.

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 299
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
at a given time divided by the total number of patients randomized to that group at Day 7) by review of medication records and urine drug test
measure
the Number of Patients Using Opioids at a Given Time
time Frame
at day 7
description
at a given time divided by the total number of patients randomized to that group at Day 90) by review of medication records and urine drug test
measure
the Number of Patients Using Opioids at a Given Time
time Frame
at day 90
description
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
measure
Symptom Burden
time Frame
At baseline
description
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
measure
Symptom Burden
time Frame
At Day 7
description
measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale
measure
Symptom Burden
time Frame
At Day 90

Full study description

brief Summary: The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.

Source references