Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Peripheral Neuropathy, Breast Cancer, Chemotherapy, Paclitaxel, Acupuncture
Brief summary
The present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer
Detailed description
Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be randomized to receive true acupuncture (intervention group) vs sham acupuncture (control), once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003) questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week 6, week 8 and week 12. The study has duration of 12 weeks.
Interventions
OTHERTrue acupuncture
The selection of acupuncture points is based on Traditional Chinese Medicine (Wen, 2011) and on previous studies (Jeong,2018; Bao,2018), selected as main points: bilateral baxie, SJ5, bafeng, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain de qi sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.
OTHERSham acupuncture
Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain de qi, located near the real points in the hands and feet. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.
Sponsors
Instituto Brasileiro de Controle do Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Sham acupuncture
Intervention model description
True acupuncture vs sham acupuncture
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years old. * Agreed to sign the Informed Consent Term * ECOG 0-1 * Breast cancer stages I, II and III. * Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m2. * Peripheral sensory neuropathy grade 2 and 3 by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Exclusion criteria
* Previous history of peripheral neuropathy due to other comorbidities. * Prior treatment with chemotherapy for cancer other than breast cancer. * Use of medications to treat peripheral neuropathy. * Metastatic disease. * Presence of lymphedema of any degree. * History of coagulopathy or full anticoagulation. * Previous acupuncture treatment for any indication within the last 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change the effects of neuropathic pain syndromes management from baseline | Screening visit (baseline), week 4, week 6, week 8, week 12 | Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline pain intensity change | Screening visit (baseline), week 4, week 6, week 8, week 12 | Visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]). |
| Change in side effects associated with taxane treatments from baseline | Screening visit (baseline), week 4, week 6, week 8, week 12 | FACT-taxane questionnaire. It is a self-report instrument that was developed to measure the health-related Quality of life of patients receiving taxane-containing chemotherapy. This scale has 16 items, including an 11-item neurotoxicity subscale and five additional taxane-specific questions related to the effects of arthralgia, myalgia, and skin changes. The total score is calculated as the sum of the un-weighted subscale score. |
Countries
Brazil
Outcome results
None listed