Balancing Method for Pain Related to Advanced Cancer

NCT ID: NCT04176575

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2024-01-20

Brief Summary

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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

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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.

Conditions

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Pain, Cancer Metastatic Cancer Invasive Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This clinical trial is a descriptive, interventional, and open-label pilot study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Ronald M. Glick, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald M Glick, MD

Role: PRINCIPAL_INVESTIGATOR

Hillman Cancer Center

Locations

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UPMC Center for Integrative Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY18120017

Identifier Type: -

Identifier Source: org_study_id

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