Chemotherapy-induced Peripheral Neuropathy
Conditions
Brief summary
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN.
Detailed description
This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
Interventions
DEVICEElectro-acupuncture
Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥18 years * Received curative-intent chemotherapy (i.e., paclitaxel, docetaxel, nab-paclitaxel, carboplatin, oxaliplatin, vinorelbine, ixabepilone, or vincristine) ≥3 months prior to the start of EA treatment * Persistent Grade ≥2 peripheral neuropathy in the fingers or toes according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 * Eastern Cooperative Oncology Group performance status of ≤2 (see Section 13.3) * Willing and able to provide written informed consent for the study.
Exclusion criteria
* Documented medical history of neuropathy resulting from nerve compression (e.g., carpal tunnel syndrome, radiculopathy, or spinal stenosis) * Severe coagulopathy or bleeding disorder, per the treating physician's discretion * Presence of cellulitis or other skin infection or condition that would preclude placement of acupuncture needles into the hands or feet * Diabetes unless Hgb A1c \<7.5% * Unstable cardiac disease * Pacemaker * Metal plates * Known psychiatric disorder that would interfere with cooperation with the requirements of the study * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program | 5 Months | Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain After a 10-treatment EA Program | Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months) | The change in neuropathic pain after a 10-treatment EA program in subjects with CIPN, was assessed by the Brief Pain Inventory Short Form (BPI-SF) at Baseline, 2-Week Post EA, and 3 Month Post EA. Used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. Pain and interference are rated on a 10-point scale (0 = no pain/interference and 10 = pain as bad as you can imagine/complete interference). Higher scores mean worse outcomes. |
| Change in Quality of Life After a 10-treatment EA Program | Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months) | Assessed by the Total Outcome Index (TOI), including the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale at Baseline, 2-Week Post EA, and 3 Month Post EA. The Total Outcome Index (TOI) ranges from 0 to 100, with higher scores consistently indicating better outcomes. Items are rated on a 0-4 Likert scale and negatively worded items are reverse scored so that higher values always reflect better health status. The neurotoxicity subscale score is calculated by summing the scored responses to the neurotoxicity items (with standard prorating if some items are missing), and the TOI is calculated by summing the Physical Well-Being, Functional Well-Being, and Neurotoxicity subscale scores. Lower scores on either measure indicate worse symptoms or functioning, while higher scores reflect improvement or better quality of life related to neurotoxicity. |
Countries
United States
Participant flow
Recruitment details
During the study period, 31 patients with early-stage breast cancer consented onto the trial. Among these, 23 met the eligibility criteria, and 20 of the 23 were enrolled and started treatment. The first patient was consented on 8/29/2019 and the last patient was consented on 4/25/2023.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 66.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed