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

Primary Purpose

Arthralgia

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

acupuncture

Guizhi-Shaoyao-Zhimu decoction

About this trial

This is an interventional treatment trial for Arthralgia focused on measuring aromatase inhibitors-associated arthralgia, aromatase inhibitors, breast cancer, musculoskeletal disorders, hormonal anti-estrogen therapy, endocrine therapy

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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).
Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist.
Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year.
Have already been recovered from the surgery or chemotherapy.
Have a ECOG performance status score of 0 to 1.
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.
Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to 2.
The patient could cooperate the intervention and sign the informed consent.

Exclusion Criteria:

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.
Had a history of fractures or underwent surgery on the knee or hand joints in the past six months.
Had severe bleeding disorders. The platelet counts are below 50,000 per μl.
Cognitive disorders (included dementia).
Lymphedema after breast cancer surgery.

Sites / Locations

ShowChwanMHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

acupuncture group

Chinese medicine group

combined group

Arm Description

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.

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.

The combined group would have both acupuncture and Chinese medicine interventions.

Outcomes

Primary Outcome Measures

Brief Pain Inventory-Worst Pain Item (BFI-WP)

a 0- to 10-point scale (0 [no pain] to 10 [pain as bad as you can imagine)

Secondary Outcome Measures

Brief Pain Inventory - Short Form (BPI-SF)

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)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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).

Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)

Affections of the Hands (M-SACRAH) was used in the evaluation of pain, stiffness, physical function of upper limb.

Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) measured physical and functional well- being and endocrine symptoms (score range, 0-128)

Full Information

NCT ID

NCT05264649

First Posted

February 20, 2022

Last Updated

November 6, 2022

Sponsor

Show Chwan Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05264649

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 5, 2022 (Actual)

Primary Completion Date

July 20, 2022 (Actual)

Study Completion Date

March 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Show Chwan Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthralgia

Keywords

aromatase inhibitors-associated arthralgia, aromatase inhibitors, breast cancer, musculoskeletal disorders, hormonal anti-estrogen therapy, endocrine therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

acupuncture group

Arm Type

Experimental

Arm Description

Arm Title

Chinese medicine group

Arm Type

Experimental

Arm Description

Arm Title

combined group

Arm Type

Experimental

Arm Description

The combined group would have both acupuncture and Chinese medicine interventions.

Intervention Type

Device

Intervention Name(s)

acupuncture

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Guizhi-Shaoyao-Zhimu decoction

Intervention Description

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.

Primary Outcome Measure Information:

Title

Brief Pain Inventory-Worst Pain Item (BFI-WP)

Description

a 0- to 10-point scale (0 [no pain] to 10 [pain as bad as you can imagine)

Time Frame

Change from baseline at 6 weeks

Secondary Outcome Measure Information:

Title

Brief Pain Inventory - Short Form (BPI-SF)

Description

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)

Time Frame

Change from baseline at 6 weeks

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Time Frame

Change from baseline at 6 weeks

Title

Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)

Description

Affections of the Hands (M-SACRAH) was used in the evaluation of pain, stiffness, physical function of upper limb.

Time Frame

Change from baseline at 6 weeks

Title

Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

Description

The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) measured physical and functional well- being and endocrine symptoms (score range, 0-128)

Time Frame

Change from baseline at 6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist. Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year. Have already been recovered from the surgery or chemotherapy. Have a ECOG performance status score of 0 to 1. 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. Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to 2. The patient could cooperate the intervention and sign the informed consent. Exclusion Criteria: 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. Had a history of fractures or underwent surgery on the knee or hand joints in the past six months. Had severe bleeding disorders. The platelet counts are below 50,000 per μl. Cognitive disorders (included dementia). Lymphedema after breast cancer surgery.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

I-Ting Lee, Bachelor

Phone

+886-988567228

iting.lee927@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

I-Ting Lee, Bachelor

Organizational Affiliation

Show Chwan Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

ShowChwanMH

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I-TING LEE, master

Phone

+886988567227

iting.lee927@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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