Clinical trial NCT02129686: A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Official title: A Randomized Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Taxane-induced Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Early-Stage Breast Carcinoma
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Keywords: Chemotherapy-induced peripheral neuropathy (CIPN)
Acupuncture
Early-Stage Breast Carcinoma
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: The Comprehensive and Integrative Medicine Institute of South Korea
First posted: 2014-05-02
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.

Detailed description: Chemotherapy drugs used to treat cancer can cause temporary or permanent damage to the nerves in the hands and feet, a condition called "chemotherapy-induced peripheral neuropathy". The most common symptoms of chemotherapy-induced peripheral neuropathy are pain, tingling, burning or numbness sensation, which can lead to balance problems or trouble using fingers or pick up/holding things. These symptoms often last months to years after the completion of chemotherapy. Medications and nutritional supplements can ease the symptoms of chemotherapy-induced peripheral neuropathy, but many patients continue to experience symptoms despite these treatments.

Acupuncture is an intervention in which hair-thin, stainless steel needles are shallowly inserted into specific points on the skin, with the goal of influencing the body's natural healing system. Acupuncture has been studied in clinical trials in cancer patients and has been shown to be effective for various conditions including chemotherapy-induced nausea and vomiting. A few preliminary studies have suggested that acupuncture may help to reduce symptoms of peripheral neuropathy, but more information is needed about the benefits of acupuncture in breast cancer patients This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.

This research study will help to determine the benefits of acupuncture for the treatment of chemotherapy-induced peripheral neuropathy. The study will also look at two different acupuncture schedules to determine whether patients derive benefits from lower and higher dose acupuncture treatments.

Eligibility criteria: Inclusion Criteria:

* History of histologically or cytologically proven breast cancer at stage I, II and III, without evidence of distant metastasis;
* Completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy
* Reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) (Table 1 and the screening checklist);
* Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12;
* Age ≥ 18 years;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Adequate hematological function: neutrophil count \>1.0 x109/L, platelet count \>50x109/L;
* Signed informed consent.

Exclusion Criteria:

* Patients with any of the following criteria will not be eligible for the study:
* Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
* Wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder;
* History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, toxic neuropathy;
* Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma;
* Pregnancy or potential pregnancy and nursing;
* Active clinically significant uncontrolled infection;
* Prior use of acupuncture for CIPN within 6 months prior to study entry;
* Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.

Primary outcomes:
measure: Response Rate from Baseline in PNQ Score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Changes in FACT/NTX subscale baseline to 8 weeks
timeFrame: Baseline, 8 Weeks
measure: Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks
timeFrame: Baseline, 8 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Weidong Lu, M.B., MPH, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu W, Giobbie-Hurder A, Freedman RA, Shin IH, Lin NU, Partridge AH, Rosenthal DS, Ligibel JA. Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial. Oncologist. 2020 Apr;25(4):310-318. doi: 10.1634/theoncologist.2019-0489. Epub 2019 Oct 14.