NCT02309164

Brief Summary

This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

September 16, 2014

Last Update Submit

November 11, 2015

Conditions

NeoplasmAdult DiseaseNeuropathy

Outcome Measures

Primary Outcomes (1)

  • neurological symptoms

    This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms of patients with chemotherapy induced peripheral neuropathy

    up to 7 weeks

Secondary Outcomes (2)

  • functional impairment

    up to 7 weeks

  • quality of life

    up to 7 weeks

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

acupuncture

Procedure: AcupunctureBehavioral: Orientation group

orientation group

SHAM COMPARATOR

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Behavioral: Orientation group

Interventions

AcupuncturePROCEDURE

10 acupuncture sessions of 30 minutes each, twice a week

Acupuncture
Orientation groupBEHAVIORAL

medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.

Acupunctureorientation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer adult patients with CIPN -

You may not qualify if:

  • Other neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cancer do Estado de São Paulo ICESP

São Paulo, São Paulo, 01246 000, Brazil

Location

Related Publications (1)

  • D'Alessandro EG, Nebuloni Nagy DR, de Brito CMM, Almeida EPM, Battistella LR, Cecatto RB. Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study. BMJ Support Palliat Care. 2022 Mar;12(1):64-72. doi: 10.1136/bmjspcare-2018-001542. Epub 2019 Jun 29.

    PMID: 31256014DERIVED

MeSH Terms

Conditions

NeoplasmsDisease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Rebeca B Cecatto, PhD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rebeca Boltes Cecatto

Study Record Dates

First Submitted

September 16, 2014

First Posted

December 5, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

BR(1)