Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer

NCT02333409 | Terminated

• 1 other identifier: EA_CA pancreas
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is the sixth most common cause of cancer death in Hong Kong. Patients suffering from pancreatic cancer are associated with a poor prognosis and survival of less than one year is expected in inoperable tumours (1). Management of these patients would be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this "intractable" pain is often difficult to treat (2). Pain management is a major part of the comprehensive therapy in patients with pancreatic cancer, and it also affects their quality of life. Electroacupuncture seems to be a promising way to control the cancer pain and reduce the dose and side effects of pain killers including opioid. This study aimed to investigate the efficacy and safety of electroacupuncture in reducing pancreatic cancer pain in patients suffering from inoperable pancreatic cancer.

Conditions

Cancer of Pancreas; Pain

Keywords

Cancer of pancreas; Acupuncture; Pain

Outcome Measures

Primary Outcomes (1)

• pain scores in numeric rating scale (NRS)

  Pain Score

  1 Month after Procedure

Secondary Outcomes (4)

• Procedural discomfort

  Day 0 after procedure

• Willingness to repeat procedure

  1 Month after Procedure

• Morbidities related to the procedures

  1 Month after Procedure

• Quality of Life scores

  1 Month after Procedure

Study Arms (2)

Electroacupuncture

ACTIVE COMPARATOR

A Hong Kong registered Chinese Medicine practitioner will give Electroacupuncture treatments. Patients will be treated in a comfortable prone position. Jiaji (Ex-B2) points form T8 to T12 bilaterally are chosen based on traditional Chinese medicine (TCM) theory and neurophysiologic basis of Jiaji points. After De Qi sensation is achieved, the handles of needles on homolateral T8-T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1 mA with a disperse-dense waveform. The needles remained for 30 min. The treatment was given twice weekly on week 1 and week 3.

Procedure: Electroacupuncture

Sham

SHAM COMPARATOR

For placebo acupuncture, sham placebo acupuncture needles (DongBang AcuPrime Acupuncture Inc., South Korea) will be used. Its validity and credibility have been well demonstrated. The needles with blunt tips are quickly put onto the same points used in the electroacupuncture group without inserting into the skin. The needles on homolateral T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

Electroacupuncture (EA) has been used as a part of Traditional Chinese Medicine (TCM) and the benefits and success of EA as a viable treatment option for acute and chronic pain of various origins have been well-recognised.electro-acupuncture (EA) is taken place as to give out the stimulation with fixed frequency, pulse width and current to acupuncture needle for further promotion of analgesics effects.

Also known as: Acupuncture

Electroacupuncture; Sham

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ≥ 18 years old with cytology or histology confirmed pancreatic cancer
• Abdominal pain typical for pancreatic cancer
• Inoperability of pancreatic cancer as demonstrated by computed tomography (CT), positron emission tomography (PET) scan or endoscopic ultrasonography (EUS).
• Informed consent available

You may not qualify if:

• Patients who are allergic to the acupuncture needles
• Coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml)
• Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
• Had been treated by acupuncture for pancreatic cancer within 1 year
• Potential patient noncompliance (refusing to follow schedule of events)
• Active alcohol or other drug use or significant psychiatric illness
• Expected survival less than 3 months
• Unable to give informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery; The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pain

Interventions

Electroacupuncture; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 7, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

HK (1)