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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma Hodgkin Disease Non-Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care plus Acupuncture

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Intervention Type DRUG

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

Assessments

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

opioid

Intervention Type DRUG

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

Assessments

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

opioid

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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No