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

Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069467
Collaborator
West China Hospital (Other), Yantai Hospital of Traditional Chinese Medicine (Other), Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine (Other), Jiangsu Cancer Institute & Hospital (Other)
240
Enrollment
3
Arms
16.9
Anticipated Duration (Months)

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: Acupuncture
  • Device: Sham Acupuncture
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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.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
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

ArmIntervention/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.

    Outcome Measures

    Primary Outcome Measures

    1. Weekly mean hot flash symptom severity score (HFSSS) [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) [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 [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) [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) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    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

    • Principal Investigator: Jiani Wu, M.D., Ph.D., Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Oct 6, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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, Dr., Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021