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Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain

Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02510066
Enrollment
62
Registered
2015-07-28
Start date
2015-07-31
Completion date
2017-06-30
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Pancreatic Cancer

Keywords

Pancreatic Cancer, Pain, Acupuncture

Brief summary

This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

Detailed description

Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.

Interventions

DEVICEAcupuncture

Disposable stainless steel filiform needles (40mm in length and 0.30mm in diameter) are inserted perpendicularly into T8-T12 Jiaji (Ex-B2) points bilaterally to a depth of 25 mm. After De Qi sensation is achieved, the handles of needles on homolateral T8 and T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1mA with a disperse-dense waveform for 30 minutes.

DEVICEPlacebo acupuncture

Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points without inserting into the skin. The needles on homolateral points at the same level as T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.

Sponsors

Shanghai Cancer Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination. * Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to 10. * Stable dose of analgesics at least 72 hours before randomization. * Expected survival time more than 1 month.

Exclusion criteria

* Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder). * Acupuncture treatment in the past. * Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points). * Unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
Pain scores, assessed with numeric rating scale (NRS)1 week

Secondary

MeasureTime frame
Karnofsky performance status (KPS) score1 week
Blood levels of β-endorphin1 week
Blood levels of nerve growth factor1 week

Countries

China

Contacts

Primary ContactHao Chen
chengkll@sina.com86-13601996751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026