Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy
This study is evaluating whether acupuncture may help reduce hot flashes in men receiving hormone therapy for prostate cancer. Hot flashes are a common side effect of androgen deprivation therapy (ADT) and may negatively affect sleep, mood, concentration, daily activities, and overall quality of life.
Participants enrolled in this study will receive acupuncture treatment over a defined treatment period. The study will assess changes in hot flash frequency, severity, and quality of life using patient questionnaires and symptom diaries. Participants will complete a daily hot flash diary during selected 7-day assessment periods and quality-of-life questionnaires during study visits.
The primary goal of this study is to determine whether acupuncture may improve hot flash symptoms and related quality of life in men undergoing treatment for prostate cancer.
調査の概要
詳細な説明
Hot flashes are a common and bothersome side effect experienced by men receiving androgen deprivation therapy (ADT) for prostate cancer. Symptoms may include sudden warmth, sweating, flushing, sleep disturbance, fatigue, mood changes, and reduced quality of life. Although medications such as antidepressants may help some patients, these treatments may also cause side effects and are not effective for all individuals. Acupuncture has been studied as a non-drug approach for management of hot flashes, but additional prospective studies are needed in men with prostate cancer receiving ADT.
This study is a prospective clinical study evaluating acupuncture for the management of ADT-related hot flashes in men with prostate cancer. Participants will undergo acupuncture treatment during the active treatment phase according to the study treatment schedule.
The study will evaluate changes in:
Hot flash frequency Hot flash severity Hot flash-related quality of life Interference of hot flashes with daily activities, sleep, mood, and social functioning
Patient-reported outcomes will be collected using standardized symptom assessments, including:
A Hot Flash Daily Diary The Hot Flash Related Daily Interference Scale (HFRDIS)
Participants will complete a daily hot flash diary during predefined 7-day assessment windows at baseline, during treatment, at the end of treatment, and during follow-up. The diary records the number and severity of hot flashes experienced over a 24-hour period. Participants will also complete questionnaires evaluating how hot flashes affect daily activities and quality of life.
The study includes follow-up assessments after completion of acupuncture treatment to evaluate the durability of symptom improvement over time.
The primary objective of the study is to assess whether acupuncture reduces hot flash burden in men receiving ADT for prostate cancer. Secondary objectives include evaluation of quality-of-life outcomes, symptom trajectory over time, treatment feasibility, and patient adherence to acupuncture-based symptom management.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Zin Myint, MD
- 電話番号：850-323-3964
- メール：zwmy222@uky.edu
研究連絡先のバックアップ
- 名前：Maria Hoover, BS
- 電話番号：859-323-3065
- メール：Maria.Hoover@uky.edu
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40536
- 募集
- University of Kentucky
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コンタクト：
- Zin Myint, MD
- メール：zin.myint@uky.edu
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主任研究者：
- Zin Myint, MD
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副調査官：
- Courtney Lantz, Dipl. Ac., L. Ac
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コンタクト：
- Maria Hoover, BS
- 電話番号：859-323-3065
- メール：Maria.Hoover@uky.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with history of prostate cancer with currently receiving hormone therapy or had received hormone therapy in the past two years
- Hormone therapies may include androgen deprivation therapy ( ADT; e.g., leuprolide, degarelix, or relugolix) or androgen signaling inhibitors (e.g., enzalutamide, apalutamide, or darolutamide) or adrenal steroid synthesis inhibitor (e.g., abiraterone acetate).
- Patients may also receive additional treatments such as chemotherapy, radioligand therapy or target therapy in combination with hormone therapy.
- Reports hot flashes at least twice per day. Patients may already be taking medications for hot flashes. There is no limit on the number of hot flash medications they can be using.
- ECOG performance status =3 (see Appendix A).
- Patients may participate in other therapeutic clinical trials for the treatment of prostate cancer. They will remain eligible as long as they meet the eligible criteria.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- Patients with a prior or concurrent malignancy are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
- Patients can't travel for acupuncture
- Patients with high bleeding tendency as determined by PI
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Real Acupuncture
Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at predefined acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the sham acupuncture arm.
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The Real Acupuncture is administered at bilateral Large Intestine 4, Kidney 7, Kidney 3, and Gall Bladder 39 points using sterile single-use filiform needles.
Needles are inserted approximately 20-25 mm with manipulation to achieve de qi sensation and retained for 30 minutes.
Treatments are administered twice weekly for 6 weeks.
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アクティブコンパレータ：Sham Acupuncture
Participants receive acupuncture administered by a licensed and NCCAOM board certified acupuncturist at non-acupuncture points twice weekly for 6 weeks followed by a 4 week washout period before participants crossover to the real acupuncture arm.
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The Sham Acupuncture administered at non-acupuncture points bilaterally using sterile single-use filiform needles.
Needles are inserted approximately 4-5 mm without manipulation.
Needles are retained for 30 minutes.
Treatments are administered twice weekly for 6 weeks.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hot Flash Score
時間枠：Baseline and week 6
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Weekly hot flash score will be calculated from a 7-day hot flash diary.
Daily hot flash score is calculated as the number of hot flashes per day multiplied by the maximum severity score for that day.
Weekly hot flash score is calculated as the sum of daily hot flash scores over 7 days.
The primary outcome is the change in weekly hot flash score from baseline to Week 6.
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Baseline and week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hot Flash Related Daily Interference Scale (HFRDIS) Score
時間枠：Baseline, Week 6, Week 16
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Change in Hot Flash Related Daily Interference Scale (HFRDIS) total score from baseline.
The HFRDIS is a validated 10-item patient-reported questionnaire assessing the impact of hot flashes on daily functioning and quality of life.
Each item is scored from 0 to 10, with higher scores indicating greater interference from hot flashes.
|
Baseline, Week 6, Week 16
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Proportion of Participants Achieving ≥50% Reduction in Weekly Hot Flash Score
時間枠：Week 6 and Week 16
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Proportion of participants achieving at least a 50% reduction in weekly hot flash score compared with baseline, based on 7-day hot flash diary assessments.
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Week 6 and Week 16
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Change in Mean Daily Hot Flash Frequency
時間枠：Baseline, Week 6, Week 16
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Change in the mean number of daily hot flashes recorded in the 7-day hot flash diary compared with baseline.
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Baseline, Week 6, Week 16
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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