Clinical trial NCT04176575: Balancing Method for Pain Related to Advanced Cancer
Official title: Acupuncture for Pain Related to Advanced Cancer Using Dr. Tan's Balancing Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Cancer
Metastatic Cancer
Invasive Cancer
Keywords: Acupuncture
Cancer Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This clinical trial is a descriptive, interventional, and open-label pilot study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline, each visit; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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
timeFrame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
measure: 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)
timeFrame: Week 5, Weeks 9-12 and follow-up; up to 18 weeks (per participant)
measure: Measuring health intervention attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Treatment Expectancy (HEAL-TEX)
timeFrame: Baseline Visit
measure: Measuring perception of effectiveness based on patient-provider connections by using Healing Encounters Attitudes List: Perception of the Patient-Provider Connection (HEAL-PPC)
timeFrame: Week 4 and Weeks 9, 10, 11, 12
measure: Measuring spiritual attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Spirituality (HEAL-SPT)
timeFrame: Baseline Visit
measure: Monitoring and recording use of opioids throughout the study protocol using Opioid Use Questionnaire
timeFrame: Baseline; weekly; follow-up; up to 18 weeks (per participant)
measure: Assessing for treatment-related adverse events as recorded by Acupuncture Safety Record
timeFrame: Baseline; each visit and follow-up; up to 18 weeks (per participant)
measure: Assessing for treatment-related and illness-related symptoms as recorded by Symptoms Checklist (SC)
timeFrame: Baseline; each visit and follow-up; up to 18 weeks (per participant)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Center for Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: Hillman Cancer Center
name: Ronald M Glick, MD
role: PRINCIPAL_INVESTIGATOR
References: