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Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL) (AVAIL)

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ClinicalTrials.gov Identifier: NCT05069467
Recruitment Status : Not yet recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborators:
West China Hospital
Yantai Hospital of Traditional Chinese Medicine
Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Jiangsu Cancer Institute & Hospital
Information provided by (Responsible Party):
Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
Hot flashes are a common and debilitating symptom among prostate cancer patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that venlafaxine provides partial relief, but the tolerability is poor when the dose is not tapered. Hence, an alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.

Condition or disease Intervention/treatment Phase
Hot Flashes Prostate Cancer Acupuncture Device: Acupuncture Device: Sham Acupuncture Not Applicable

Detailed Description:

The number of men surviving after being diagnosed with prostate cancer has increased rapidly. According to population-based cancer registry data, 10-year survival has tripled in the past 40 years in the UK. Androgen deprivation therapy (ADT) is a mainstay of prostate cancer treatment and has been shown in randomized controlled trials to improve overall survival when used with radiation for intermediate- and high-risk localized disease, as well as locally advanced and node-positive disease, and after surgery for the node-positive disease. Although ADT can improve survival, it can also cause significant morbidity and a decrement in quality of life. One of the most bothersome side effects is hot flashes. They are experienced as sudden and transient episodes of heat and sweating, with possible co-occurring palpitations and anxiety, usually persist long-term. The prevalence estimated that 44-80% of patients undergoing ADT report hot flashes and up to 27% report this as the most troublesome adverse effect. Although hot flashes are not fatal morbidity, it may interfere with adherence to lifesaving therapies or ablative therapies that are used to prevent or treat cancer.

Currently, most intervention studies for hot flashes have evaluated treatments in breast cancer patients or women who are postmenopausal. Venlafaxine, a selective serotonin reuptake inhibitor, appears to be effective and safe in both breast cancer women and prostate cancer men with hot flashes. It has been recommended for practice in men with strong evidence from multiple rigorously designed studies. However, some prostate cancer patients cannot take venlafaxine because of side effects such as nausea, headache, dry mouth, dizziness, insomnia, and constipation. Thus, an alternative therapy is needed. A systematic review identified six studies of acupuncture for hot flashes, of which none were randomized and placebo-controlled. Although acupuncture is a nonpharmacologic therapy and has been confirmed that could be helpful in the management of hot flashes among breast cancer survivors, there is no placebo acupuncture-controlled trials demonstrating its efficacy in men.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly 2:1:1 allocated to the true acupuncture (n=120), sham acupuncture (n=60), or usual care (n=60) group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Licensed acupuncturists with more than 5 years of experience will be responsible for administering interventions three times per week for 6 weeks. The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling. Acupuncture was defined as targeting the 10 bilateral acupuncture points: Xinshu (BL15), Shenshu (BL23), Zhongliao (BL33), Sanyinjiao (SP6), Yinlingquan (SP9). The needle will be left in place for 30 minutes with brief manipulation at the beginning, middle, and end of therapy.
Device: Acupuncture
For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling.

Sham Comparator: Sham Acupuncture
Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
Device: Sham Acupuncture
Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
Other Names:
  • Placebo Needle
  • Non-penetrating Acupuncture

No Intervention: Usual Care
Patients receiving usual care received neither acupuncture nor sham acupuncture. After the 6-week assessment, patients will be offered the option to receive acupuncture treatment as the acupuncture group.



Primary Outcome Measures :
  1. Weekly mean hot flash symptom severity score (HFSSS) [ Time Frame: Baseline to week 6 ]
    The HFSSS is defined as the product of "hot frequency" and "hot severity". The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).


Secondary Outcome Measures :
  1. Weekly mean hot flash symptom severity score (HFSSS) [ Time Frame: Baseline to week 14 ]
    The HFSSS is defined as the product of "hot frequency" and "hot severity". The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).

  2. Response rate of HFSSS [ Time Frame: Baseline, week 6, and week 14 ]
    The responders will be defined according to a 50% reduction of HFSSS

  3. Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: Baseline, week 6, and week 14 ]
    The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire is a relevant, worldwide tool used for assessing the health-related quality of life in men with prostate cancer.

  4. EQ-5D-three-level version (EQ-5D-3L) [ Time Frame: Baseline, week 6, and week 14 ]
    The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions.

  5. International Index of Erectile Function (IIEF-5) [ Time Frame: Baseline, week 6, and week 14 ]
    The IIEF-15 comprises 15 items divided into 5 domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction, respectively. The IIEF-5 comprises 5 items from the IIEF-15, 4 from the erectile function domain, and 1 from intercourse satisfaction. Response options for each item ranged from 1 to 5, and occasionally the option "0" depicting no sexual stimulation/intercourse, the scores are summed.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

patients aging from 18 to 75 years diagnosed with prostate cancer undergoing ADT; with an average of 3 or more hot flashes a day for at least 3 days before enrollment and no other clinically significant disease; not receiving any medications for hot flashes nor did they have a previous history of acupuncture treatment.

Exclusion Criteria:

hormonal treatment other than GnRH analogue, daily treatment with psychotropic drugs, newly started or changed alternative medications with possible effects on flushes uncontrolled hypertension or metabolic disease, inability to move/lie on the side, and treatment with anticoagulants or a pacemakers.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069467


Contacts
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Contact: Jiani Wu, M.D., Ph.D. 13426116653 jiani_wu@aliyun.com
Contact: Zongshi Qin, M.D. 17888808861 arisq@hku.hk

Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
West China Hospital
Yantai Hospital of Traditional Chinese Medicine
Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine
Jiangsu Cancer Institute & Hospital
Investigators
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Principal Investigator: Jiani Wu, M.D., Ph.D. Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Responsible Party: Jiani Wu, Dr., Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT05069467    
Other Study ID Numbers: 2020030KY02
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The deidentified participant data will be shared after publication. Researchers can access the data with a specific purpose and a signed data access agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: With publication
Access Criteria: For a specified purpose with a signed data access agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jiani Wu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Prostate Cancer
Hot Flashes
Acupuncture
Randomized Controlled Trial
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases