Hodgkin Disease, Multiple Myeloma, Non-Hodgkin Lymphoma
Conditions
Keywords
Pain management, Acupuncture, 20-264
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.
Interventions
OTHERAcupuncture
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.
DRUGopioid
All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.
OTHERAssessments
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.
Sponsors
Patient-Centered Outcomes Research Institute
Hackensack Meridian Health
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Number of Patients Using Opioids at a Given Time | at day 7 | 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 |
| Symptom Burden | At baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 151 |
| 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. | 147 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease progression | 0 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 10 |
Baseline characteristics
| Characteristic | Acupuncture Plus Usual Care | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 58.4 years | 58.3 years | 58.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 22 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants | 276 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 35 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 114 Participants | 235 Participants | 121 Participants |
| Region of Enrollment United States | 151 Participants | 298 Participants | 147 Participants |
| Sex: Female, Male Female | 73 Participants | 141 Participants | 68 Participants |
| Sex: Female, Male Male | 78 Participants | 157 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 147 |
| other Total, other adverse events | 39 / 151 | 0 / 147 |
| serious Total, serious adverse events | 0 / 151 | 0 / 147 |
Outcome results
Primary
Symptom Burden
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
Time frame: At baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Plus Usual Care | Symptom Burden | 2.06 MDASIBMT Total Symptom Severity score |
| Usual Care | Symptom Burden | 2.06 MDASIBMT Total Symptom Severity score |
Primary
Symptom Burden
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
Time frame: At Day 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Plus Usual Care | Symptom Burden | 2.96 MDASIBMT Total Symptom Severity score |
| Usual Care | Symptom Burden | 2.95 MDASIBMT Total Symptom Severity score |
Primary
Symptom Burden
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
Time frame: At Day 90
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Plus Usual Care | Symptom Burden | 1.46 MDASIBMT Total Symptom Severity score |
| Usual Care | Symptom Burden | 1.40 MDASIBMT Total Symptom Severity score |
Primary
the Number of Patients Using Opioids at a Given Time
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
Time frame: at day 7
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acupuncture Plus Usual Care | the Number of Patients Using Opioids at a Given Time | Using Opioid | 35 Participants |
| Acupuncture Plus Usual Care | the Number of Patients Using Opioids at a Given Time | No Opioid Use | 106 Participants |
| Usual Care | the Number of Patients Using Opioids at a Given Time | Using Opioid | 43 Participants |
| Usual Care | the Number of Patients Using Opioids at a Given Time | No Opioid Use | 91 Participants |
Primary
the Number of Patients Using Opioids at a Given Time
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
Time frame: at day 90
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acupuncture Plus Usual Care | the Number of Patients Using Opioids at a Given Time | Using Opioid | 6 Participants |
| Acupuncture Plus Usual Care | the Number of Patients Using Opioids at a Given Time | No Opioid Use | 135 Participants |
| Usual Care | the Number of Patients Using Opioids at a Given Time | Using Opioid | 8 Participants |
| Usual Care | the Number of Patients Using Opioids at a Given Time | No Opioid Use | 126 Participants |