Clinical trial · Interventional
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL)
Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Device | — | UNRESOLVED |
| Sham Acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Acupuncture
- description
- 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.
- interventionNames
- Device: Acupuncture
- type
- SHAM_COMPARATOR
- label
- Sham Acupuncture
- description
- 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.
- interventionNames
- Device: Sham Acupuncture
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDQin Z, Zang Z, Yu J, Lv J, Li N, Zhang J, Yang M, Kwong JSW, Pang R, Wang J, Cui Z, Yu Y, Wang H, Zhu Y, Yuan Y, Li X, Wu Y, Wu J. Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial. BMC Complement Med Ther. 2023 Oct 27;23(1):388. doi: 10.1186/s12906-023-04218-y. PMID 37891531