Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma
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| ClinicalTrials.gov Identifier: NCT04459416 |
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Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : December 23, 2022
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Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
Patient-Centered Outcomes Research Institute
Hackensack Meridian Health
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma Hodgkin Disease Non-Hodgkin Lymphoma | Other: Acupuncture Drug: opioid Other: Assessments | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Opioid-Sparing Pain Treatment In Myeloma And Lymphoma Patients Undergoing High-Dose Chemotherapy (OPTIMAL-HiChemo): Randomized Controlled Trial |
| Actual Study Start Date : | June 30, 2020 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Other: 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. Drug: opioid All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Other: 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. |
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Active Comparator: 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.
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Drug: opioid
All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Other: 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. |
Primary Outcome Measures :
- the number of patients using opioids at a given time [ Time Frame: up to 90 days ]at a given time divided by the total number of patients randomized to that group at Day 7 and Day 90) by review of medication records and urine drug test
- symptom burden [ Time Frame: up to 90 days ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459416
Contacts
| Contact: Gary Deng, MD, PhD | 646-888-0841 | dengg@mskcc.org | |
| Contact: Sergio Giralt, MD | 212-639-3859 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Gary Deng, MD, PhD 646-888-0815 | |
| Contact: Sergio Giralt, MD 212-639-3859 | |
| Principal Investigator: Gary Deng, MD, PhD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Not yet recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Heather Greenlee, MD 206-667-4502 | |
| Seattle Cancel Care Alliance (Data Collection Only) | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Heather Greenlee, MD 206-606-7222 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Patient-Centered Outcomes Research Institute
Hackensack Meridian Health
Investigators
| Principal Investigator: | Gary Deng, MD, PhD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT04459416 |
| Other Study ID Numbers: |
20-264 |
| First Posted: | July 7, 2020 Key Record Dates |
| Last Update Posted: | December 23, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Pain management Acupuncture 20-264 |
Additional relevant MeSH terms:
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Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |