Acupuncture Treatment for Hot Flashes Study | NCT00421902

Studies
Acupuncture Treatment for Hot Flashes Study

NCT00421902

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006Actual

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jan 12, 2007

First Submission Date that Met QC Criteria

Jan 12, 2007

First Posted Date

Jan 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2020

Last Update Posted Date

Sep 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hani Ashamalla, MD, Chairman of Radiation Oncology Department, New York Presbyterian Brooklyn Methodist HospitalPrincipal Investigator

Lead Sponsor

New York Presbyterian Brooklyn Methodist HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture	Experimental	Acupuncture of the patients	Procedure: Acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure	Patients will be have acupuncture (with electro stimulation)	Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief from the hot flashes as determined by the hot flashes scoring system.	A Questionnaire was given to the patients to determine the relief of hot flashes	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment for prostate cancer using hormonal ablation therapy
Average of three or more hot flashes a day
Performance Status (Karnofsky ≥ 60)
Patients must be ≥ 18 years of age
No other clinically significant disease
Signed study-specific consent form prior to study entry

Exclusion Criteria:

Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
Skin infections
Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hani Ashamalla, MD, FCCP	NY Methodist Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYP- Brooklyn Methodist Hospital		Brooklyn	New York	11215	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20605360	Derived	Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.

ID	Term
D011471	Prostatic Neoplasms
D019584	Hot Flashes

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics