Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer

November 6, 2022 updated by: Lee I-Ting, Show Chwan Memorial Hospital
Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause, but side effects, such as joint pain, would affect their qualities of life. Chinese herbs or acupuncture provides promising clinical effects and plays an important role on alleviating the side effects of cancer treatment. This clinical trial will evaluate the effect of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Reduce estrogen exposure can lower the risk of breast cancer recurrence. Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause for years. It can increase the survival rate and decrease the chance of recurrence. However, many patients suffered from the side effects of medication, including joint pain, is the main reason for decreasing medication adherence and influencing patients' quality of life. Based on previous phase III clinical trial study, acupuncture may relieve aromatase inhibitor associated joint pain, and experts believe that acupuncture could also be considered as an effective adjuvant treatment. Chinese herbs or acupuncture provides promising clinical effects and plays an important role in alleviating the side effects of cancer treatment. Guizhi-Shaoyao-Zhimu decoction has frequently being prescribed to treat joint pain in traditional Chinese medicine practice. The design of this clinical trial will evaluate the effects of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancer. The goal of this study was to evaluate the efficacy and safety with regards to utilizing acupuncture and Chinese herbs in treating joint pain related to the usage of aromatase inhibitors.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with diagnosis of early breast cancer (stages I-III), expressing hormone receptor-positive (ER+, PR+, or both) and took third generation aromatase inhibitors (AIs).
  2. Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist.
  3. Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year.
  4. Have already been recovered from the surgery or chemotherapy.
  5. Have a ECOG performance status score of 0 to 1.
  6. Joint pain which has developed or worsened since starting AIs therapy. The worst pain item score of Brief Pain Inventory-Short Form (BPI-SF) is at least 3 and above.
  7. Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to 2.
  8. The patient could cooperate the intervention and sign the informed consent.

Exclusion Criteria:

  1. Had received acupuncture treatment for joint pain would be excluded, but patients with acupuncture treatment for less than 2 times due to other reasons could be included.
  2. Had a history of fractures or underwent surgery on the knee or hand joints in the past six months.
  3. Had severe bleeding disorders. The platelet counts are below 50,000 per μl.
  4. Cognitive disorders (included dementia).
  5. Lymphedema after breast cancer surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupuncture group
Stainless steel, disposable, sterile needles choosing based on the needs of different body parts (0.22 gauge x 25mm, 0.22 gauge x 40mm, or 0.25 gauge x 100mm) were inserted to acupoints at traditional depths and angles.
Device: acupuncture
The acupuncture group were consisted of twelve 30 minutes sessions 2 times per week sessions for 6 weeks. The acupoints were included full body protocol (LI4, LR3, and PC7) and joint-specific protocol tailored as many as three of the patient's most painful joint areas. After 20 minutes "De Qi" reported by patients, needles were restimulated manually and removed after an additional 10 minutes.
Experimental: Chinese medicine group
The Chinese medicine group used Guizhi-Shaoyao-Zhimu decoction (GZSD) as their medical intervention. The GZSD samples were made and packed by Sun Ten Pharmaceutical Co. Ltd., a firm that meets the requirements of the good manufacturing practice (GMP) certification in Taiwan. Every 4g of concentrated GZSD was sealed in an isolated paper drug bag.
Drug: Guizhi-Shaoyao-Zhimu decoction
The patients consumed GZSD (4g paper bagged medicine) three times per day (total daily dose was 12 g/day) continuously during the 6-week intervention period.
Experimental: combined group
The combined group would have both acupuncture and Chinese medicine interventions.
Device: acupuncture
The acupuncture group were consisted of twelve 30 minutes sessions 2 times per week sessions for 6 weeks. The acupoints were included full body protocol (LI4, LR3, and PC7) and joint-specific protocol tailored as many as three of the patient's most painful joint areas. After 20 minutes "De Qi" reported by patients, needles were restimulated manually and removed after an additional 10 minutes.
Drug: Guizhi-Shaoyao-Zhimu decoction
The patients consumed GZSD (4g paper bagged medicine) three times per day (total daily dose was 12 g/day) continuously during the 6-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory-Worst Pain Item (BFI-WP)
Time Frame: Change from baseline at 6 weeks
a 0- to 10-point scale (0 [no pain] to 10 [pain as bad as you can imagine)
Change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory - Short Form (BPI-SF)
Time Frame: Change from baseline at 6 weeks
The Brief Pain Inventory-Short Form (BPI-SF) was used to evaluate the worst pain, pain severity, and pain- related interference scores. (0 [no pain] to 10 [pain as bad as you can imagine)
Change from baseline at 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Change from baseline at 6 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used in the evaluation of pain (score range, 0-20), stiffness (score range, 0-8), physical function of lower limb (score range, 0-68).
Change from baseline at 6 weeks
Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
Time Frame: Change from baseline at 6 weeks
Affections of the Hands (M-SACRAH) was used in the evaluation of pain, stiffness, physical function of upper limb.
Change from baseline at 6 weeks
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Time Frame: Change from baseline at 6 weeks
The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) measured physical and functional well- being and endocrine symptoms (score range, 0-128)
Change from baseline at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Show Chwan Memorial Hospital

Investigators

  • Principal Investigator: I-Ting Lee, Bachelor, Show Chwan Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

July 20, 2022

Study Completion (Anticipated)

March 3, 2023

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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