ArthralgiaNCT05264649
Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
A study testing acupuncture and Guizhi-Shaoyao-Zhimu decoction in people with Arthralgia, run by Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Arthralgia
- What is being tested?
- acupuncture and Guizhi-Shaoyao-Zhimu decoction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
ShowChwanMH
Changhua, 500
I-TING LEE, master, +886988567227, iting.lee927@gmail.com
About this study
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.
Read the 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.
- Conditions
- Arthralgia
- Being tested
- acupuncture, Guizhi-Shaoyao-Zhimu decoction
- Keywords
- aromatase inhibitors-associated arthralgia, aromatase inhibitors, breast cancer, musculoskeletal disorders, hormonal anti-estrogen therapy, endocrine therapy
- Medical subject headings
- Arthralgia, Breast Neoplasms, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
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.
Guizhi-Shaoyao-Zhimu decoctionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | 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. Receives: Device: acupuncture |
| Chinese medicine group | Experimental | 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. Receives: Drug: Guizhi-Shaoyao-Zhimu decoction |
| combined group | Experimental | The combined group would have both acupuncture and Chinese medicine interventions. Receives: Device: acupuncture; Drug: Guizhi-Shaoyao-Zhimu decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline at 6 weeks
Secondary outcomes (4)
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)
Measured: Change from baseline at 6 weeks
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).
Measured: Change from baseline at 6 weeks
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.
Measured: Change from baseline at 6 weeks
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)
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start5 May 2022
- Primary completion20 Jul 2022
- Study completion3 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee I-Ting, Show Chwan Memorial Hospital
- Investigators
- I-Ting Lee, Bachelor, Principal investigator, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264649
- Sponsor's protocol ID
- 1100903
- Status last verified
- Nov 2022
- First submitted
- 20 Feb 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05264649
- Acronym / sponsor ID
- 1100903
- Conditions
- Arthralgia
- Keywords
- aromatase inhibitors-associated arthralgia, aromatase inhibitors, breast cancer, musculoskeletal disorders, hormonal anti-estrogen therapy, endocrine therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 3 Mar 2023 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Device: acupunctureStainless 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. |
| Chinese medicine group | Experimental | Drug: Guizhi-Shaoyao-Zhimu decoctionThe 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. |
| combined group | Experimental | Device: acupuncture, Drug: Guizhi-Shaoyao-Zhimu decoctionThe combined group would have both acupuncture and Chinese medicine interventions. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureThe 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. | Device | acupuncture group, combined group |
| Guizhi-Shaoyao-Zhimu decoctionThe 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. | Drug | Chinese medicine group, combined group |
Primary outcome
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)
4 secondary outcomes
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: Change from baseline at 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 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
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Time frame: Change from baseline at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Ting Lee, Bachelor principal investigator
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Guizhi-Shaoyao-Zhimu decoction in people with Arthralgia, run by Show Chwan Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Ting Lee, Bachelor (+886-988567228, iting.lee927@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory-Worst Pain Item (BFI-WP) (time frame: Change from baseline at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.