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OpenTrials
Completed

NCT Number: NCT04176575

Balancing Method for Pain Related to Advanced Cancer

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

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Key information

Conditions

Pain, Cancer Cancer Pain Invasive Cancer Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15218, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Experience with acupuncture within the prior 3 months.
  • Platelet count < 50,000.
  • Absolute Neutrophil Count < 1,000.
  • Treatment with anticoagulant medication, other than prophylactic levels of heparin or low molecular weight heparin preparations or anti-platelet agents.
  • Known coagulopathy.
  • 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.

Treatment and study plan

Acupuncture

Other

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 25, 2019
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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