NCT04459416 · OUTCOME

the Number of Patients Using Opioids at a Given Time

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma · Source last updated 2025-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: at day 7

What was measured

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

Groups in this outcome

Acupuncture Plus Usual Care

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. Acupuncture: 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. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: 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.

Usual Care

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. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Acupuncture Plus Usual Care	141
Usual Care	134

Reported measurements

Source class 1

Using Opioid

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Acupuncture Plus Usual Care	35	Not reported	Not reported	Not reported	Not reported
Usual Care	43	Not reported	Not reported	Not reported	Not reported

No Opioid Use

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Acupuncture Plus Usual Care	106	Not reported	Not reported	Not reported	Not reported
Usual Care	91	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
35
group Id
OG001
value
43
title
Using Opioid
measurements
group Id
OG000
value
106
group Id
OG001
value
91
title
No Opioid Use

denoms

counts
group Id
OG000
value
141
group Id
OG001
value
134
units
Participants

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

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. Acupuncture: 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. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: 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.
id
OG000
title
Acupuncture Plus Usual Care
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. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: 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.
id
OG001
title
Usual Care

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

at day 7

title

the Number of Patients Using Opioids at a Given Time

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice