Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

NCT00244894 | Terminated DMC

• 3 other identifiers: CDR0000445180OHSU-7235OHSU-HOR-02029-LX
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer. PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.

Conditions

Fatigue; Hot Flashes; Prostate Cancer

Keywords

fatigue; recurrent prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer; hot flashes

Outcome Measures

Primary Outcomes (3)

• Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment

  Weeks 4 after initiation of study treatment.

• Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment

  10 Weeks after initiation of study treatment.

• Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 16 weeks after initiation of study treatment

  16 Weeks after initiation of study treatment.

Secondary Outcomes (5)

• Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 4 weeks after initiation of study treatment

  4 Weeks after initiation of study treatment.

• Change in biomarkers at baseline after initiation of study treatment

  Baseline after initiation of study treatment.

• Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 10 weeks after initiation of study treatment

  10 weeks after initiation of study treatment.

• Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 16 weeks after initiation of study treatment

  16 Weeks after intiation of study treatment.

• Change in biomarkers at 4 weeks after initiation of study treatment

  4 Weeks after initiation of study treatment.

Interventions

acupuncture therapy PROCEDURE

Acupuncture treatments will be administered by a qualified practitioner twice a week for the first four weeks and once per week for an additional 6 weeks. Sterile, disposable Seirin needles will be placed bilaterally at the point Gallbladder 34, and along the spine at Bladder 15, Bladder 23, and Bladder 32. Low intensity electrostimulation at 2 Hz will be used for both Bladder 23 and Bladder 32. Points will also be placed unilaterally at Governing vessel 20, Heart 7, Pericardium 6, Liver 2, and Spleen 6

fatigue assessment and management PROCEDURE

Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.

hot flashes attenuation PROCEDURE

Patients will be asked to report hot flash frequency and severity daily using the hot flash diary (HFD) and hot flash severity guidelines (HFSG) throughout the treatment period.

management of therapy complications PROCEDURE

Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.

quality-of-life assessment PROCEDURE

Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Confirmed diagnosis of prostate cancer * Hot flash score ≥ 4 per day * Prior or concurrent treatment with 1 of the following : * Bilateral orchiectomy * Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy * Antiandrogen therapy PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No mental impairment PRIOR CONCURRENT THERAPY: Chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * More than 4 weeks since prior estrogen or progestational drugs Surgery * See Disease Characteristics * No prior placement of a pacemaker or other implantable electrical device Other * More than 4 weeks since prior gabapentin * No concurrent antidepressant drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Fatigue; Hot Flashes; Prostatic Neoplasms

Interventions

Acupuncture Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 2002
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (2)