Back to resultsA Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Primary Purpose
Taxane-induced Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy (CIPN), Early-Stage Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Acupuncture Group
Delayed Acupuncture Group
Sponsored by
About this trial
This is an interventional supportive care trial for Taxane-induced Peripheral Neuropathy focused on measuring Chemotherapy-induced peripheral neuropathy (CIPN), Acupuncture, Early-Stage Breast Carcinoma, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
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.
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Acupuncture Group
Delayed Acupuncture Group
Arm Description
Immediate acupuncture arm will receive acupuncture 3 times per week during week 1 and week 2, then 2 times per week from week 2 to week 8 for a total of 18 sessions. The crossover will take place after 8th week. The immediate acupuncture arm will enter a follow-up phase without acupuncture for 8 weeks from week 9 to week 16, while the standard usual care will be provided.
The patients on the usual care/delayed acupuncture arm will continue their standard usual care with their physicians and care team. The crossover will take place after 8th week. After crossover, the patients initially on the usual care/delayed acupuncture arm will receive the identical acupuncture protocol but a less frequent schedule from week 9 to week 16: 2 times per week at week 9, then 1 time per week from week 10 to week 16 for a total of 9 sessions
Outcomes
Primary Outcome Measures
Response Rate from Baseline in PNQ Score
The PNQ includes two questionnaire items: one asking about sensory neurotoxicity and the other asking about motor neurotoxicity. The questionnaire items correspond to the neurotoxicity questions included in the NCI-CTCAE. PNQ grades range from grade A (no neuropathy) to grade E (very severe neuropathy). Answer options will be coded 0=A to 4=E, with a higher score indicating more severe CIPN
Secondary Outcome Measures
Changes in FACT/NTX subscale baseline to 8 weeks
Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks
Comprised of three subscales assessing sensory, motor, and autonomic symptoms. Subscale scores will be calculated and linearly transformed to a 0 to 100 scale, with higher scores suggesting more severe symptoms. Changes from baseline (8-week - baseline) between the intervention arms for each subscale will be of interest.
Full Information
NCT ID
NCT02129686
First Posted
April 30, 2014
Last Updated
July 26, 2021
Sponsor
Dana-Farber Cancer Institute
Collaborators
The Comprehensive and Integrative Medicine Institute of South Korea
1. Study Identification
Unique Protocol Identification Number
NCT02129686
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
September 15, 2016 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
The Comprehensive and Integrative Medicine Institute of South Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Acupuncture Group
Arm Type
Experimental
Arm Description
Immediate acupuncture arm will receive acupuncture 3 times per week during week 1 and week 2, then 2 times per week from week 2 to week 8 for a total of 18 sessions. The crossover will take place after 8th week.
The immediate acupuncture arm will enter a follow-up phase without acupuncture for 8 weeks from week 9 to week 16, while the standard usual care will be provided.
Arm Title
Delayed Acupuncture Group
Arm Type
Active Comparator
Arm Description
The patients on the usual care/delayed acupuncture arm will continue their standard usual care with their physicians and care team. The crossover will take place after 8th week. After crossover, the patients initially on the usual care/delayed acupuncture arm will receive the identical acupuncture protocol but a less frequent schedule from week 9 to week 16: 2 times per week at week 9, then 1 time per week from week 10 to week 16 for a total of 9 sessions
Intervention Type
Procedure
Intervention Name(s)
Immediate Acupuncture Group
Intervention Type
Procedure
Intervention Name(s)
Delayed Acupuncture Group
Primary Outcome Measure Information:
Title
Response Rate from Baseline in PNQ Score
Description
The PNQ includes two questionnaire items: one asking about sensory neurotoxicity and the other asking about motor neurotoxicity. The questionnaire items correspond to the neurotoxicity questions included in the NCI-CTCAE. PNQ grades range from grade A (no neuropathy) to grade E (very severe neuropathy). Answer options will be coded 0=A to 4=E, with a higher score indicating more severe CIPN
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Changes in FACT/NTX subscale baseline to 8 weeks
Time Frame
Baseline, 8 Weeks
Title
Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks
Description
Comprised of three subscales assessing sensory, motor, and autonomic symptoms. Subscale scores will be calculated and linearly transformed to a 0 to 100 scale, with higher scores suggesting more severe symptoms. Changes from baseline (8-week - baseline) between the intervention arms for each subscale will be of interest.
Time Frame
Baseline, 8 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Lu, M.B., MPH, Ph.D
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32297442
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160396/
Description
Related Info
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A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
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