Back to resultsAcupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer
Primary Purpose
Peripheral Neuropathy Due to Chemotherapy
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
True acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Neuropathy Due to Chemotherapy focused on measuring Peripheral Neuropathy, Breast Cancer, Chemotherapy, Paclitaxel, Acupuncture
Eligibility Criteria
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.
Sites / Locations
- Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
A - true acupuncture
B - sham acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The change the effects of neuropathic pain syndromes management from baseline
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 Outcome Measures
Baseline pain intensity change
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
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.
Full Information
NCT ID
NCT04461977
First Posted
July 2, 2020
Last Updated
July 7, 2020
Sponsor
Instituto Brasileiro de Controle do Cancer
1. Study Identification
Unique Protocol Identification Number
NCT04461977
Brief Title
Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer
Official Title
Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Brasileiro de Controle do Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy Due to Chemotherapy
Keywords
Peripheral Neuropathy, Breast Cancer, Chemotherapy, Paclitaxel, Acupuncture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
True acupuncture vs sham acupuncture
Masking
Participant
Masking Description
Sham acupuncture
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A - true acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
B - sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
True acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
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 Outcome Measure Information:
Title
The change the effects of neuropathic pain syndromes management from baseline
Description
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.
Time Frame
Screening visit (baseline), week 4, week 6, week 8, week 12
Secondary Outcome Measure Information:
Title
Baseline pain intensity change
Description
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]).
Time Frame
Screening visit (baseline), week 4, week 6, week 8, week 12
Title
Change in side effects associated with taxane treatments from baseline
Description
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.
Time Frame
Screening visit (baseline), week 4, week 6, week 8, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin I Ter, MD
Phone
+5511984736737
Email
LINITER@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alayne Yamada, PhD
Email
alayne.pesquisa@ibcc-mooca.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin I Ter, MD
Organizational Affiliation
Instituto Brasileiro de Controle do Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03102-006
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alayne D Yamada, PhD
Phone
+55113473-4249
Email
alayne.pesquisa@ibcc-mooca.org.br
First Name & Middle Initial & Last Name & Degree
Lin I Ter, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15030944
Citation
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
Results Reference
background
PubMed Identifier
12910528
Citation
Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31. doi: 10.1002/cncr.11578.
Results Reference
background
PubMed Identifier
30420895
Citation
Jeong YJ, Kwak MA, Seo JC, Park SH, Bong JG, Shin IH, Park SH. Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. Evid Based Complement Alternat Med. 2018 Oct 21;2018:5367014. doi: 10.1155/2018/5367014. eCollection 2018.
Results Reference
background
PubMed Identifier
30007894
Citation
Bao T, Seidman AD, Piulson L, Vertosick E, Chen X, Vickers AJ, Blinder VS, Zhi WI, Li Q, Vahdat LT, Dickler MN, Robson ME, Mao JJ. A phase IIA trial of acupuncture to reduce chemotherapy-induced peripheral neuropathy severity during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in breast cancer patients. Eur J Cancer. 2018 Sep;101:12-19. doi: 10.1016/j.ejca.2018.06.008. Epub 2018 Jul 13.
Results Reference
background
PubMed Identifier
22128801
Citation
de Andrade DC, Ferreira KA, Nishimura CM, Yeng LT, Batista AF, de Sa K, Araujo J, Stump PR, Kaziyama HH, Galhardoni R, Fonoff ET, Ballester G, Zakka T, Bouhassira D, Teixeira MJ. Psychometric validation of the Portuguese version of the Neuropathic Pain Symptoms Inventory. Health Qual Life Outcomes. 2011 Nov 30;9:107. doi: 10.1186/1477-7525-9-107.
Results Reference
background
Citation
Wen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.
Results Reference
background
Links:
URL
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
Description
Common Terminology Criteria for Adverse Events ( CTCAE ) version 5.0.
Learn more about this trial
Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer
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