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NCT04459416 · OUTCOME

Symptom Burden

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
MEAN
Unit
MDASIBMT Total Symptom Severity score
Interval / dispersion
95% Confidence Interval
Time frame
At Day 90

What was measured

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

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

GroupSource count
Acupuncture Plus Usual Care141
Usual Care134

Reported measurements

Source class 1
Values in MDASIBMT Total Symptom Severity score · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Acupuncture Plus Usual Care1.46Not reported1.201.72Not reported
Usual Care1.40Not reported1.121.68Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.20
        upper Limit
        1.72
        value
        1.46
      2. group Id
        OG001
        lower Limit
        1.12
        upper Limit
        1.68
        value
        1.40
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    2. group Id
      OG001
      value
      134
    units
    Participants
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
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
MEAN
reporting Status
POSTED
time Frame
At Day 90
title
Symptom Burden
type
PRIMARY
unit Of Measure
MDASIBMT Total Symptom Severity score

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

Preserved source evidence · Not medical advice