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NCT Number: NCT04461977

Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer

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

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Key information

Conditions

Peripheral Neuropathy Due to Chemotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)

São Paulo, 03102-006, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

True acupuncture

Other

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.

Sham Acupuncture

Other

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.

Primary outcomes

  1. The change the effects of neuropathic pain syndromes management from baseline

    Time frame: 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 outcomes

  1. Baseline pain intensity change

    Time frame: 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]).

  2. Change in side effects associated with taxane treatments from baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Controle do Cancer

Other

Registry information

Official study title

Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 8, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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