Sensation DisordersNCT02615678
Acupuncture for CIPN in Breast Cancer Patients
A study testing Acupuncture in people with Sensation Disorders and Neuropathy, run by Southern California University of Health Sciences at 1 site in United States.
Trial summary
The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sensation Disorders, Neuropathy
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of 18 years of age
- Currently receiving neurotoxic chemotherapy
- Experiencing symptoms of chemotherapy induced neuropathy for at least 1 month
- Have a minimum score of 3 on the VAS should have a grade II CIPN on NCICTC
- Willing to sign an informed consent
- Stable treatment for more than two months before screening
- Stable treatment is defined as no change in the type and dose of medications 2 months prior to enrollment.
- Once enrolled, the patients will be asked to remain on the same type and dose of the medications for neuropathy
Who cannot join
- Receiving any treatment to prevent neuropathy 2 weeks prior to the screening
- Pre-existing peripheral neuropathy due to any other cause than chemotherapy
- Pre-existing conditions like pregnancy, uncontrolled diabetes, hypertension, cardiovascular disorders, bleeding disorders, depression (BDI > 21)
- Unwilling to follow the protocol
- Individuals who are receiving government disability assistance
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California University of Health Sciences
Whittier, California, 90604
About this study
Official title: Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series
The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.
Read the detailed description
Ideally 10 patients experiencing peripheral neuropathy due to chemotherapy from breast cancer treatment will be included in this study.They will receive 16 total acupuncture treatments over 10 weeks including various points based off of research and classical text and scalp acupuncture.
- Conditions
- Sensation Disorders, Neuropathy
- Being tested
- Acupuncture
- Keywords
- neuropathy, peripheral, chemotherapy, breast cancer
- Medical subject headings
- Sensation Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture including scalp needling will be applied to selected points based on literature Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perceived neuropathy as measured by EORTC CIPN-20
This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale.
Measured: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Secondary outcomes (3)
Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire
Measured: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain
Measured: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in quality of life as measured by EORTC QLQ-30
Measured: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensation DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sivarama Vinjamury, Southern California University of Health Sciences
- Investigators
- Sivarama Vinjamury, MD, MAOM, Principal investigator, Southern California University of Health Sciences, College of Eastern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615678
- Sponsor's protocol ID
- VINJ007
- Status last verified
- May 2019
- First submitted
- 21 Nov 2015
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series
- ClinicalTrials.gov ID
- NCT02615678
- Acronym / sponsor ID
- VINJ007
- Conditions
- Sensation Disorders, Neuropathy
- Keywords
- neuropathy, peripheral, chemotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.
Detailed description
Ideally 10 patients experiencing peripheral neuropathy due to chemotherapy from breast cancer treatment will be included in this study.They will receive 16 total acupuncture treatments over 10 weeks including various points based off of research and classical text and scalp acupuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureAcupuncture including scalp needling will be applied to selected points based on literature |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Minimum of 18 years of age
- Currently receiving neurotoxic chemotherapy
- Experiencing symptoms of chemotherapy induced neuropathy for at least 1 month
- Have a minimum score of 3 on the VAS should have a grade II CIPN on NCICTC
- Willing to sign an informed consent
Key exclusion criteria (5 listed)
- Receiving any treatment to prevent neuropathy 2 weeks prior to the screening
- Pre-existing peripheral neuropathy due to any other cause than chemotherapy
- Pre-existing conditions like pregnancy, uncontrolled diabetes, hypertension, cardiovascular disorders, bleeding disorders, depression (BDI > 21)
- Unwilling to follow the protocol
- Individuals who are receiving government disability assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks. | Device | Acupuncture |
Primary outcome
Changes in perceived neuropathy as measured by EORTC CIPN-20
Time frame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale.
3 secondary outcomes
Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire
Time frame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain
Time frame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Changes in quality of life as measured by EORTC QLQ-30
Time frame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivarama Vinjamury, MD, MAOM principal investigator
Southern California University of Health Sciences, College of Eastern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Sensation Disorders and Neuropathy, run by Southern California University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in perceived neuropathy as measured by EORTC CIPN-20 (time frame: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.