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A randomized controlled trial to evaluate the efficacy of adjuvant HANS therapy in Chinese cancer pain patients with opioid tolerance

A randomized controlled trial to evaluate the efficacy of adjuvant HANS therapy in Chinese cancer pain patients with opioid tolerance

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004087
Enrollment
Unknown
Registered
2013-12-12
Start date
2013-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Cancer pain

Interventions

Experimental(Arm1):treated with routine analgesics and Han’s Accupoint
Placebo Comparator (Arm 2):treated with routine analgesics and MOCK-HANS

Sponsors

the First Affiliated Hospital of General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed malignancies (clinical diagnosis was adequate for hepatocellular carcinoma and pancreatic cancer); 2. 18-80 years of age; 3. KPS score>=40; 4. The expected survival time >=1 month; 5. Persistent cancer pain >=1 month; 6. Ongoing opioid therapy and resulted opioid tolerance (According to the U.S Food and Drug Administration, "patients considered opioid tolerant are those who are taking at least: 60mg oral morphine/day, 25mcg transdermal fentanyl/hour, 30mg oral oxycodone/day, 8mg oral hydromorphone/day, 25mg oxymorphone/day, or an equivalent analgesic dose of another opioid for one week or longer".); 7. Conscious, able to read, write and complete the survey questionnaires; 8. The patients themselves agreed to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Pacemaker; 2. Pregnancy; 3. High fever; receiving systemic chemotherapy or local radiation of the pain (1) Pregnant or lactating women; (2) Hyperpyrexia; (3) Cognitive impairment or communication disorders; (4) Severe functional abnormalities of the heart, liver and kidneys; (5) Radiotherapy of the pain sites, systemic chemotherapy or other anticancer therapies 1 week before enrollment and during the study; (6) Placement of pacemakers; (7) Local infective inflammation and ulcers or dysesthesia/paresthesia at the electrode attachment skin sites; (8) Patient with poor compliance.

Design outcomes

Primary

MeasureTime frame
pain intensity and daily function interfered assessed by BPI-C at basline and on the 8th and the 15th days;Opioid analgesic usage (total dose in morphine equivalents);

Secondary

MeasureTime frame
the frequency of the breakthrough (BT) pain;quality of life assessed by using EORTC-C30;anxiety and depression assessed by using SADS;side effects of HANS;

Countries

China

Contacts

Public ContactXiao Wenhua

Department of Medical Oncology, the First Affiliated Hospital of Chinese PLA General Hospital

w_hxiao@hotmail.com+86 13681532672

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026