An interventional study of acupuncture in Randomized Controlled Trial, Breast Cancer and Chemotherapy-induced Peripheral Neuropathy, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
Peripheral neuropathy is currently the second most common side effect after chemotherapy, second only to the side effects of blood toxicity. A variety of chemotherapy drugs may induce peripheral neurotoxicity and cause by the cumulative dose of chemotherapy drugs. Symptoms include sensory paresthesia, feeling dullness or numbness, glove-like feeling distributed in the palm. The currently most effective way is to interrupt the treatment or adjust the dose of chemotherapeutic drugs, but it is easy to make patients discontinue chemotherapy. The purpose of this study is to explore the impact of acupuncture on neurological symptoms and quality of life. Three kinds of questionnaires will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13 (Version 4) to assess changes in neurological symptoms; (3) World Health Organization Quality of Life Scale-(WHOQOL-BREF) to assess changes in the quality of life of patients. The course of treatment was evaluated for nine weeks. Changes in neurological function and quality of life will be evaluated before treatment, the third week of treatment, the sixth week of treatment, till the ninth week. The aim of this study is to confirm that acupuncture can improve peripheral neuropathy after chemotherapy, in order to enhance breast cancer patients' quality of life, and provide the new opportunity for integrative therapy between Chinese and Western medicine.
Keywords：acupuncture , chemotherapy-induced peripheral neuropathy
(I) Background of the research A variety of neurotoxic chemotherapeutic agents, including platinums (e.g. cisplatin, carboplatin, and oxaliplatin), taxanes (e.g. paclitaxel and docetaxel), and vinca alkaloids (e.g. vincristine and vinblastine), thalidomide and bortezomib, may induce peripheral neuropathy. Generally speaking, sensory nerve dysfunction is more common than motor involvement. It causes hands and feet to feel tingling, dullness or numbness symmetrically, which will be a glove-like ("glove-and-stocking type") sensation distributed in palms and soles. Patient's touch, vibration, and proprioception senses may be impaired under clinical examinations.
chemotherapy-induced peripheral neuropathy(CIPN) relates to the cumulative doses of chemotherapeutic agents. Sometimes, when chemotherapy is stopped, neuropathy symptoms may continue or worsen, which is called a "costing phenomenon". Nerve damaging usually starts from ends of the extremities, while individual doses were accumulated, it gradually extends to proximal joints or ganglions. CIPN is currently the second most common side, next to hematotoxicity. Within thirty days after chemotherapy, 68.1% of patients may develop CIPN, most of which can be relieved or improved, but there are still 30-83% symptoms persist over 6 months.
At present, the most effective way to treat CIPN is to stop the treatment protocol or adjust doses of chemotherapy; however, it affects the effect of chemotherapy in degrading tumor growth. Plenty of pharmacological or non-pharmacological treatments are still under investigation, such as antioxidant medication (e.g. Acetyl-L-carnitine, glutamine, vit B12, fish oil, etc.), anxiolytics (e.g. venlafaxine), neuroprotective agents (e.g. infusion of calcium ions, magnesium ions), food supplements, acupuncture, light stimulation, etc. Acupuncture with the advantages of clinically effective, easy-practice and relatively safe, few studies revealed its effect on CIPN, however, there is still a lack of large clinical trials to evaluate its effectiveness.
(ii) Purpose of the research To investigate the efficacy of acupuncture on peripheral neuropathy after chemotherapy administration in patients with breast cancer.
(iii) Importance of the research Current studies revealed that acupuncture might be effective on CIPN, however, insufficient number of participants or lack of control groups limit the quality of clinical studies. Therefore, the aim of our study to conduct a randomized controlled clinical trial to evaluate the efficacy of acupuncture on peripheral neuropathy caused by chemotherapy.
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The inclusion criteria will be: female more than 20 years of age; breast cancer with early stage at I-III; had completed chemotherapy; the neurotoxic chemotherapeutic agents included taxanes, platinums, or others; less than grade three in the Eastern Cooperative Oncology Group (ECOG) status; higher than grade one in National Cancer Institute-common terminology criteria for adverse events(NCI-CTCAE) scale.
The exclusion criteria will be: having less than three months in mean survival time, history of diabetic neuropathy before chemotherapy administration, history of other preexisting peripheral neuropathy, other inflammatory or metabolic arthritis, severe blood coagulation diseases or with latent bleeding tendency, unstable cardiovascular diseases, or other preexisting muscle-skeletal diseases.
Acupuncture treatment will be performed for 9 weeks. Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
Other: acupuncture
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
Other: acupuncture
More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, Limited., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
The average pain severity was chosen as the primary assessment as neuropathy symptoms based on its ability to detect neuropathic pain in cancer patients, as well as its use to assess CIPN symptoms in other controlled clinical trials.The BPI-SF assesses pain when responding to the questionnaire (right now) and at its worst, least, and average pain severity in the last 24 h. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. We analyzed the data (1) within group analysis: compared the data at week 6 with baseline, and the data at week 9 with baseline from each group. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 6 and week 9. (3) the between group differences of the changes from week 6 to baseline and from week 9 to baseline.
Time frame: We measured the average pain severity 4 times within 9 weeks [at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol].
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
The 27-item FACT-G evaluated the quality of life of patients undergoing cancer therapy over the past 7 days. The question is rated on a five-point scale, from 0 to 4 (0= not at all; 4= very much) and summed ( total score range= 0-108). An increase in scores represents an improvement in the overall quality of life.The 13-item Ntx subscale measures the severity and impact of neurotoxicity symptoms over the past seven days. Items are rated on a five-point scale, scored from 0 to 4 and summed ( total score range= 0-52). Higher scores on the neurotoxicity scale indicate improvements in neurotoxic symptoms. The 40-item FACT/GOG-Ntx total score represents the sum of the FACT-G and Ntx subscale (total score range=0-160).The FACT/GOG-Ntx trial outcome index (TOI) contained the scores of the PWB, FWB, and FACT/GOG-Ntx subscale (total score range= 0-104).We analyzed the data (1) within group analysis(2) between group analysis(3) the changes between group analysis
Time frame: 4 times within 9 weeks: at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
WHOQOL-BREF Taiwan version was validated to be a good clinical tool across five kinds of Taiwanese cancer survivors. There are a total 28 items by adding 2 additional items to account for Taiwanese cultural adaptations. Item scores range from 1 to 5 (1 =the worst condition; 5=the best condition), except for 3 items (Ph1, Ph2, and Ps6), which are reverse coded. Each domain in the scale can be translated into two ranges of domain scores (0-100 and 4-20), and we used 0-100 scale in this study. The Higher scores in each domain indicate the better quality of life for patients with cancers We analyzed the data (1) within group analysis: compared post-treatment with baseline. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 9. (3) the between group differences of the changes from post-treatment to baseline.
Time frame: We measured 2 times within 9 weeks: before and after treatment
Touch Test Sensory Evaluator
Measurements were performed using a set of 20 von Frey monofilaments(Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, U.S.A.), with evaluator size/target forces from 1.65/0.008 gto 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Thresholds for categories of tactile perception were defined by the filament manufacturer as follows: normal ; diminished light touch; diminished protective sensation; loss of protective sensation; deep pressure sensation only . All tests were performed by an independent assessor who was unaware of the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer. Measuring sites include: LHT(Left hand's middle fingertip);LHP(Left hand's palm);RHT(Right hand's middle fingertip);RHP(Right hand's palm);LFT(Left foot's big toe tip);LFP(Left foot's plantar);RFT(Right foot's big toe tip);RFP(Right foot's plantar)
Time frame: 2 times within 9 weeks: before and after treatment
Explore the Neuroprotective Mechanism of Acupuncture
15 cc of blood samples will be drawn before and after 15 sessions of treatments from participants in both groups. The blood samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) for tumor necrosis factor-alfa and interleukin- 6, interleukin-10 and brain-derived nuerotrophic factor to evaluate the differences in the inflammation state of peripheral nervous system within and between groups.
Time frame: 2 times within 9 weeks: before and after treatment
269 patients diagnosed with breast cancer were screened from June 2018 to July 2020. Of 61 potentially eligible patients, 20 (32.8%) were enrolled and randomized as 10 in the acupuncture group and 10 in the sham acupuncture group. 208 ineligible patients were excluded, and 41 patients declined to participate in our study.
| Milestone | The Acupuncture Group | The Controlled Group |
|---|---|---|
| Started | 10 | 10 |
| Completed | 8 | 10 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
The average pain severity was chosen as the primary assessment as neuropathy symptoms based on its ability to detect neuropathic pain in cancer patients, as well as its use to assess CIPN symptoms in other controlled clinical trials.The BPI-SF assesses pain when responding to the questionnaire (right now) and at its worst, least, and average pain severity in the last 24 h. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. We analyzed the data (1) within group analysis: compared the data at week 6 with baseline, and the data at week 9 with baseline from each group. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 6 and week 9. (3) the between group differences of the changes from week 6 to baseline and from week 9 to baseline.
| score on a scale | The Acupuncture Group | The Controlled Group |
|---|---|---|
| Baseline | 3.10 ± 2.33 | 3.10 ± 1.79 |
| Week 3 | 1.72 ± 1.48 | 3.50 ± 2.27 |
| Week 6 | 1.63 ± 0.92 | 2.78 ± 2.82 |
| Week 9 | 0.88 ± 1.13 | 2.70 ± 2.00 |
| Changes at week 6 | -1.63 ± 1.85 | -0.11 ± 2.71 |
| Changes at week 9 | -2.38 ± 2.39 | -0.40 ± 2.07 |
The 27-item FACT-G evaluated the quality of life of patients undergoing cancer therapy over the past 7 days. The question is rated on a five-point scale, from 0 to 4 (0= not at all; 4= very much) and summed ( total score range= 0-108). An increase in scores represents an improvement in the overall quality of life.The 13-item Ntx subscale measures the severity and impact of neurotoxicity symptoms over the past seven days. Items are rated on a five-point scale, scored from 0 to 4 and summed ( total score range= 0-52). Higher scores on the neurotoxicity scale indicate improvements in neurotoxic symptoms. The 40-item FACT/GOG-Ntx total score represents the sum of the FACT-G and Ntx subscale (total score range=0-160).The FACT/GOG-Ntx trial outcome index (TOI) contained the scores of the PWB, FWB, and FACT/GOG-Ntx subscale (total score range= 0-104).We analyzed the data (1) within group analysis(2) between group analysis(3) the changes between group analysis
| score on a scale | The Acupuncture Group | The Controlled Group |
|---|---|---|
| NtxS-baseline | 37.60 ± 6.08 | 33.90 ± 7.87 |
| NtxS-week 3 | 37.89 ± 6.01 | 33.62 ± 6.52 |
| NtxS-week 6 | 41.00 ± 6.72 | 36.44 ± 8.71 |
| NtxS-week 9 | 40.88 ± 7.72 | 35.90 ± 5.92 |
| NtxS-Changes at week 6 | 3.63 ± 5.07 | 1.56 ± 7.55 |
| NtxS-Changes at wee 9 | 3.50 ± 4.90 | 2.00 ± 6.96 |
| TOI-baseline | 76.60 ± 14.74 | 67.80 ± 15.25 |
| TOI-week 3 | 77.04 ± 16.03 | 69.57 ± 13.39 |
| TOI-week 6 | 81.75 ± 19.03 | 73.44 ± 16.54 |
| TOI-week 9 | 80.42 ± 20.58 | 74.60 ± 11.91 |
| TOI-changes at week 6 | 6.63 ± 7.41 | 3.00 ± 14.34 |
| TOI-changes at week 9 | 5.29 ± 6.31 | 6.80 ± 12.62 |
| FACT-G score-baseline | 79.70 ± 16.35 | 69.73 ± 14.19 |
| FACT-G score-week 3 | 77.96 ± 20.02 | 73.20 ± 15.95 |
| FACT-G score-week 6 | 80.08 ± 19.80 | 73.49 ± 16.16 |
| FACT-G score-week 9 | 77.54 ± 21.55 | 77.73 ± 11.10 |
| FACT-G score-changes at week 6 | 1.06 ± 2.89 | 1.66 ± 12.94 |
| FACT-G score-changes at week 9 | -1.48 ± 5.51 | 8 ± 10.31 |
| FACT/GOG-Ntx total score-baseline | 117.30 ± 20.56 | 103.63 ± 19.75 |
| FACT/GOG-Ntx total score-week 3 | 115.85 ± 23.80 | 106.82 ± 18.34 |
| FACT/GOG-Ntx total score-week 6 | 121.08 ± 25.93 | 109.93 ± 20.79 |
| FACT/GOG-Ntx total score-week 9 | 118.42 ± 28.55 | 113.43 ± 12.80 |
| FACT/GOG-Ntx total score-changes at week 6 | 4.69 ± 7.39 | 3.21 ± 18.40 |
| FACT/GOG-Ntx total score-changes at week 9 | 2.02 ± 8.01 | 9.80 ± 14.30 |
WHOQOL-BREF Taiwan version was validated to be a good clinical tool across five kinds of Taiwanese cancer survivors. There are a total 28 items by adding 2 additional items to account for Taiwanese cultural adaptations. Item scores range from 1 to 5 (1 =the worst condition; 5=the best condition), except for 3 items (Ph1, Ph2, and Ps6), which are reverse coded. Each domain in the scale can be translated into two ranges of domain scores (0-100 and 4-20), and we used 0-100 scale in this study. The Higher scores in each domain indicate the better quality of life for patients with cancers We analyzed the data (1) within group analysis: compared post-treatment with baseline. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 9. (3) the between group differences of the changes from post-treatment to baseline.
| score on a scale | The Acupuncture Group | The Controlled Group |
|---|---|---|
| Physical health-baseline | 60.80 ± 15.97 | 55.20 ± 12.69 |
| Physical health-post-Tx | 60.88 ± 17.88 | 59.50 ± 11.34 |
| Physical health-Changes at post-Tx | 3.63 ± 13.52 | 4.30 ± 13.36 |
| Psychological-baseline | 51.40 ± 13.79 | 45.20 ± 16.58 |
| Psychological-post-Tx | 55.50 ± 18.62 | 52.50 ± 13.52 |
| Psychological-changes at post-Tx | 6.13 ± 11.79 | 7.30 ± 8.14 |
| Social relationships-baseline | 62.10 ± 9.56 | 54.50 ± 10.22 |
| Social relationships-post Tx | 68.00 ± 11.15 | 58.90 ± 10.80 |
| Social relationships-changes at post-Tx | 6.88 ± 9.69 | 4.40 ± 11.90 |
| Environment-baseline | 61.90 ± 8.20 | 61.40 ± 13.02 |
| Environment-post Tx | 61.75 ± 10.33 | 66.30 ± 11.84 |
| Environment-changes at post-Tx | -1.63 ± 11.60 | 4.90 ± 10.97 |
Measurements were performed using a set of 20 von Frey monofilaments(Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, U.S.A.), with evaluator size/target forces from 1.65/0.008 gto 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Thresholds for categories of tactile perception were defined by the filament manufacturer as follows: normal ; diminished light touch; diminished protective sensation; loss of protective sensation; deep pressure sensation only . All tests were performed by an independent assessor who was unaware of the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer. Measuring sites include: LHT(Left hand's middle fingertip);LHP(Left hand's palm);RHT(Right hand's middle fingertip);RHP(Right hand's palm);LFT(Left foot's big toe tip);LFP(Left foot's plantar);RFT(Right foot's big toe tip);RFP(Right foot's plantar)
| grams | The Acupuncture Group | The Controlled Group |
|---|---|---|
| LHT-baseline | 1.64 ± 1.87 | 1.62 ± 1.41 |
| LHT-post-Tx | 0.41 ± 0.66 | 1.82 ± 2.28 |
| LHT-changes at post-Tx | -1.54 ± 2.12 | 0.20 ± 2.51 |
| LHP-baseline | 2.60 ± 4.69 | 1.98 ± 2.89 |
| LHP-post-Tx | 0.25 ± 0.23 | 1.44 ± 1.99 |
| LHP-changes at post-Tx | -2.92 ± 5.20 | -0.54 ± 1.73 |
| RHT-baseline | 1.52 ± 1.35 | 1.74 ± 1.31 |
| RHT-post-Tx | 0.37 ± 0.29 | 1.25 ± 1.78 |
| RHT-changes at post-Tx | -1.43 ± 1.37 | -0.50 ± 2.20 |
| RHP-baseline | 2.50 ± 4.53 | 1.91 ± 1.85 |
| RHP-post-Tx | 0.28 ± 0.20 | 1.27 ± 1.77 |
| RHP-changes at post-Tx | -2.75 ± 5.06 | -0.64 ± 1.13 |
| LFT-baseline | 14.02 ± 30.57 | 10.30 ± 17.99 |
| LFT-post-Tx | 2.50 ± 2.49 | 3.50 ± 3.41 |
| LFT-changes at post-Tx | -14.87 ± 34.46 | -6.80 ± 16.04 |
| LFP-baseline | 20.66 ± 56.17 | 9.61 ± 18.09 |
| LFP-post-Tx | 2.35 ± 5.13 | 3.24 ± 4.60 |
| LFP-changes at post-Tx | -23.40 ± 57.43 | -6.36 ± 13.99 |
| RFT-baseline | 12.80 ± 17.30 | 5.28 ± 7.55 |
| RFT-post-Tx | 2.43 ± 2.94 | 4.94 ± 4.71 |
| RFT-changes at post-Tx | -12.45 ± 19.99 | -0.34 ± 7.15 |
| RFP-baseline | 6.46 ± 6.53 | 9.36 ± 18.01 |
| RFP-post-Tx | 2.87 ± 5.06 | 3.94 ± 3.77 |
| RFP-changes at post-Tx | -4.93 ± 6.11 | -5.41 ± 15.95 |
15 cc of blood samples will be drawn before and after 15 sessions of treatments from participants in both groups. The blood samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) for tumor necrosis factor-alfa and interleukin- 6, interleukin-10 and brain-derived nuerotrophic factor to evaluate the differences in the inflammation state of peripheral nervous system within and between groups.
No measurements were reported for this outcome.
Collected over A total of nine weeks from the start of the study to the end of the study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The Acupuncture Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| The Controlled Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | The Acupuncture Group | The Controlled Group | Total |
|---|---|---|---|
| Mean | 47.10 ± 11.07 | 52.10 ± 11.18 | 49.60 ± 11.13 |
| Sex: Female, Male(Participants) | The Acupuncture Group | The Controlled Group | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | The Acupuncture Group | The Controlled Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | The Acupuncture Group | The Controlled Group | Total |
|---|---|---|---|
| Taiwan | 10 | 10 | 20 |
| Eastern Cooperative Group(ECOG) performance status(Participants) | The Acupuncture Group | The Controlled Group | Total |
|---|---|---|---|
| Grade 0 | 10 | 9 | 19 |
| Grade 1 | 0 | 1 | 1 |
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Peripheral Nervous System Diseases→
China Medical University Hospital