Acupuncture on Chemotherapy-induced Peripheral Neuropathy

Not Applicable

Completed

Conditions: Randomized Controlled Trial
Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Acupuncture

Interventions: Procedure: acupuncture

Registration Number: NCT03626220

Lead Sponsor: China Medical University Hospital

Brief Summary: 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

Detailed Description: (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture group	acupuncture	acupuncture with de-chi sensation
sham acupuncture group	acupuncture	skin-deep acupuncture without de-chi sensation

Primary Outcome Measures

Name	Time	Method
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)	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].	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.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13	4 times within 9 weeks: at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol	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
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)	We measured 2 times within 9 weeks: before and after treatment	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.
Touch Test Sensory Evaluator	2 times within 9 weeks: before and after treatment	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)