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Balancing Method for Pain Related to Advanced Cancer

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ClinicalTrials.gov Identifier: NCT04176575
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Ronald M. Glick, MD, University of Pittsburgh

Study Description
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Brief Summary:
Balancing Method for Pain Related to Advanced Cancer seeks to confirm the benefit of acupuncture for patients with pain related to advanced cancer.

Condition or disease Intervention/treatment Phase
Pain, Cancer Metastatic Cancer Invasive Cancer Other: Acupuncture Not Applicable

Detailed Description:
Pain is common among patients with cancer, with estimates as high as 90% for those with advanced disease. Opioid medication, the most common treatment, has potential adverse effects including nausea and fatigue, further interfering with quality of life. Acupuncture has been studied for the treatment of cancer-related pain, with promising results in a few methodologically sound studies with small sample size. Prior studies have found beneficial effects of open treatment using a Traditional Chinese Medicine (TCM)-based acupuncture protocol and Dr. Tan's Balancing Method. This open trial seeks to confirm the benefit of acupuncture, utilizing Dr. Tan's Balancing Method, for patients with pain related to advanced cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This clinical trial is a descriptive, interventional, and open-label pilot study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Pain Related to Advanced Cancer Using Dr. Tan's Balancing Method
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : October 5, 2023
Estimated Study Completion Date : October 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture

Eligible participants:

  • have advanced stage cancer and associated pain
  • will receive up to 12 acupuncture sessions
  • will attend sessions at UPMC's Center for Integrative Medicine
  • will complete study assessments at each visit
  • will complete a follow-up 4 to 6 weeks after their last acupuncture visit. Total study involvement will range from 16 to 18 weeks.
 Other: Acupuncture
Acupuncture involves inserting thin needles into precise points on the body, known as acupuncture points, for therapeutic effect. Acupuncture will be provided by a licensed acupuncturist utilizing Dr. Tan's Balancing Method.


Outcome Measures
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Primary Outcome Measures :
  1. Measuring effectiveness of acupuncture by assessing change in pain ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Numeric Rating Scale v.1.0 - Pain Intensity 1a (NRS) [ Time Frame: Baseline, each visit; up to 18 weeks (per participant) ]
    Participant report of pain on average on a scale from 'no pain' (0) to "worst imaginable pain" (10). Higher scores mean worse outcome.

  2. Measuring effectiveness of acupuncture by assessing change in pain intensity ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Pain Intensity Scale [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "no pain" (1) to "very severe" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  3. Measuring effectiveness of acupuncture by assessing change in pain interference ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Pain Interference Short Form 4a [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "not at all" (1) to "very much" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  4. Measuring effectiveness of acupuncture by assessing change in fatigue ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Fatigue Short Form 4a [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "not at all" (1) to "very much" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  5. Measuring effectiveness of acupuncture by assessing change in anxiety symptom ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Emotional Distress-Anxiety - Short Form 4a [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "never" (1) to "always" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  6. Measuring effectiveness of acupuncture by assessing change in sleep disturbance ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Sleep Disturbance - Short Form 4a [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "very poor/very much" (1) to "very good/not at all" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  7. Measuring effectiveness of acupuncture by assessing change in gastrointestinal symptom ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Gastrointestinal Nausea and Vomiting [ Time Frame: Baseline, each week, at follow-up; up to 18 weeks (per participant) ]
    Participant report of symptoms in the past week on a scale from "never" (1) to "always" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.

  8. Measuring effectiveness of acupuncture by assessing improvement in global symptoms ratings at Week 4 and Weeks 9-12 and 4 week follow-up using Patient Global Index of Change: Improvement (PGIC-I) [ Time Frame: Week 5, Weeks 9-12 and follow-up; up to 18 weeks (per participant) ]
    Participant rating of symptom severity on a scale of -2 (much better) to 2 (much worse). Higher scores mean worse outcome. This measure assesses changes in symptoms over the course of study participation.

  9. Measuring health intervention attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Treatment Expectancy (HEAL-TEX) [ Time Frame: Baseline Visit ]
    Participant report of treatment expectancy on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher treatment expectancy.

  10. Measuring perception of effectiveness based on patient-provider connections by using Healing Encounters Attitudes List: Perception of the Patient-Provider Connection (HEAL-PPC) [ Time Frame: Week 4 and Weeks 9, 10, 11, 12 ]
    Participant report of the patient-provider connection on a 5 point scale ranging from "Not at all" to "Very much". Higher scores ("Very much") mean better outcome. This measure assesses a change in the patient-provider connection from the beginning of study participation to the end.

  11. Measuring spiritual attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Spirituality (HEAL-SPT) [ Time Frame: Baseline Visit ]
    Participant report of Spirituality on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher personal spiritual belief.

  12. Monitoring and recording use of opioids throughout the study protocol using Opioid Use Questionnaire [ Time Frame: Baseline; weekly; follow-up; up to 18 weeks (per participant) ]
    Internally-developed, participant report of pain medication use. This questionnaire collects dosing/frequency information, which is used to calculate morphine equivalent dosing (MED). This information will be used to assess change in pain medication use over the course of study participation.

  13. Assessing for treatment-related adverse events as recorded by Acupuncture Safety Record [ Time Frame: Baseline; each visit and follow-up; up to 18 weeks (per participant) ]
    Internally-developed, participant report of acupuncture related adverse events. Administered in a checklist form. More selections on this form means more acupuncture related adverse events.

  14. Assessing for treatment-related and illness-related symptoms as recorded by Symptoms Checklist (SC) [ Time Frame: Baseline; each visit and follow-up; up to 18 weeks (per participant) ]
    Captures new or worsening health problems participants have experienced since their last study visit. More selections on this form means worse outcome.


Eligibility Criteria
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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:

  1. Age 18 or older.
  2. Current diagnosis of a malignancy.
  3. Locally invasive, metastatic, or systemic involvement from the disease, which would be anticipated to produce pain.
  4. Average pain level, on a numeric rating scale, of 4/10 or higher on the Numeric Rating Scale (NRS).
  5. Receiving treatment through Hillman Cancer Center, Magee Hospital, or 1 of the University of Pittsburgh Cancer Institute sites.
  6. Able to read and write English.

Exclusion Criteria:

  1. Experience with acupuncture within the prior 3 months.
  2. Platelet count < 50,000.
  3. Absolute Neutrophil Count < 1,000.
  4. Treatment with anticoagulant medication, other than prophylactic levels of heparin or low molecular weight heparin preparations or anti-platelet agents.
  5. Known coagulopathy.
  6. Pregnancy. While it is unlikely that any patients undergoing advanced cancer treatment will be pregnant, given the lack of documented safety, this is an exclusion.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04176575


Contacts
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Contact: Leah C Northrop, MS 4126236872 northroplc@upmc.edu
Contact: Ronald M Glick, MD 4126236872 glickrm@upmc.edu

Locations
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United States, Pennsylvania
UPMC Center for Integrative Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15218
Contact: Leah C Northrop, MS    412-623-6872    northroplc@upmc.edu   
Contact: Brittany Kail, BSBA    412-623-1203    kailb@upmc.edu   
Principal Investigator: Ronald Glick         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Ronald M Glick, MD Hillman Cancer Center
More Information
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Responsible Party: Ronald M. Glick, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04176575    
Other Study ID Numbers: HCC 21-182
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronald M. Glick, MD, University of Pittsburgh:
Acupuncture
Cancer Pain
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations