Balancing Method for Pain Related to Advanced Cancer

Acupuncture for Pain Related to Advanced Cancer Using Dr. Tan's Balancing Method

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

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer; Invasive Cancer; Pain, Cancer
• Intervention / Treatment: Other: Acupuncture

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah C Northrop, MS; Phone Number: 4126236872; Email: northroplc@upmc.edu
• Study Contact Backup: Name: Ronald M Glick, MD; Phone Number: 4126236872; Email: glickrm@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15218
      • UPMC Center for Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Participant report of pain on average on a scale from 'no pain' (0) to "worst imaginable pain" (10). Higher scores mean worse outcome.	Baseline, each visit; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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	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.	Baseline, each week, at follow-up; up to 18 weeks (per participant)
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)	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.	Week 5, Weeks 9-12 and follow-up; up to 18 weeks (per participant)
Measuring health intervention attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Treatment Expectancy (HEAL-TEX)	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.	Baseline Visit
Measuring perception of effectiveness based on patient-provider connections by using Healing Encounters Attitudes List: Perception of the Patient-Provider Connection (HEAL-PPC)	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.	Week 4 and Weeks 9, 10, 11, 12
Measuring spiritual attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Spirituality (HEAL-SPT)	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.	Baseline Visit
Monitoring and recording use of opioids throughout the study protocol using Opioid Use Questionnaire	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.	Baseline; weekly; follow-up; up to 18 weeks (per participant)
Assessing for treatment-related adverse events as recorded by Acupuncture Safety Record	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.	Baseline; each visit and follow-up; up to 18 weeks (per participant)
Assessing for treatment-related and illness-related symptoms as recorded by Symptoms Checklist (SC)	Captures new or worsening health problems participants have experienced since their last study visit. More selections on this form means worse outcome.	Baseline; each visit and follow-up; up to 18 weeks (per participant)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Ronald M Glick, MD, Hillman Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: STUDY18120017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No