Acupuncture for hot flashes in prostate cancer patients
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
This study is testing if acupuncture can help reduce hot flashes in prostate cancer patients who are receiving hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Trial ID | NCT05069467 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of acupuncture compared to sham acupuncture and usual care in alleviating hot flashes experienced by prostate cancer patients undergoing androgen deprivation therapy (ADT). Hot flashes are a common side effect of ADT, significantly impacting the quality of life for many patients. The trial aims to provide a randomized controlled evaluation of acupuncture as a potential alternative treatment, addressing the need for effective management options for this debilitating symptom. Participants will be monitored for the frequency and severity of hot flashes throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 to 75 diagnosed with prostate cancer who are undergoing ADT and experience frequent hot flashes.
Not a fit: Patients currently receiving hormonal treatments other than GnRH analogues or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological treatment option for managing hot flashes in prostate cancer patients, improving their quality of life.
How similar studies have performed: Previous studies have shown acupuncture to be beneficial for managing hot flashes in other populations, but this specific approach in prostate cancer patients is less explored.
Eligibility criteria
Show full inclusion / exclusion 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 pacemaker.
Where this trial is running
Nanjing, Jiangsu and 2 other locations
- Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
- Yantai Hospital of Traditional Chinese Medicine — Yantai, Shandong, China (Recruiting)
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Jiani Wu, M.D., Ph.D. — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study coordinator: Jiani Wu, M.D., Ph.D.
- Email: jiani_wu@aliyun.com
- Phone: 13426116653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.