NCT02081612

Brief Summary

This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable breast-cancer

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

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

3.5 years

First QC Date

March 5, 2014

Last Update Submit

July 16, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    24 weeks

Secondary Outcomes (2)

  • Maintenance of weight loss

    24 months

  • Recurrence of breast cancer

    5 years

Study Arms (2)

Nutrition Education

ACTIVE COMPARATOR

Educational weight management group sessions alone

Behavioral: Nutrition Education

Nutrition Education Plus Acupuncture

ACTIVE COMPARATOR

Educational weight management group sessions in addition to weight loss acupuncture

Behavioral: Nutrition EducationProcedure: Acupuncture

Interventions

Nutrition EducationBEHAVIORAL

12 educational weight management group session each addressing a different weight loss topic

Nutrition EducationNutrition Education Plus Acupuncture
AcupuncturePROCEDURE

12 weight loss acupuncture session using both body and auricular points.

Nutrition Education Plus Acupuncture

Eligibility Criteria

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

You may qualify if:

  • Woman with a diagnosis of breast cancer, stage I, II, or III
  • Age ≥ 18
  • ECOG performance status ≤ 1
  • Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
  • BMI ≥ 30
  • Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
  • Signed informed consent
  • Any receptor status
  • Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations

You may not qualify if:

  • Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
  • Diagnosis of metastatic breast cancer
  • Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
  • Current use of commercial or natural/herbal weight loss supplements
  • Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
  • Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • Personal history of an eating disorder
  • Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutrition AssessmentAcupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthComplementary TherapiesTherapeutics

Study Officials

  • Amy Tiersten, MD

    Icahn School of Medicine at Mount Sinai

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

September 1, 2014

Primary Completion

March 6, 2018

Study Completion

December 1, 2018

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

US(1)