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NCT Number: NCT02871999

Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.

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Key information

Conditions

Gastrointestinal Carcinoma Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
  • Pathology diagnosed;
  • Brain, heart, lung, liver, kidney are at good condition before surgery;
  • No mental disorder, no conscious obstacle, no limbs disability.

Exclusion criteria

  • Severely complication after surgery;
  • Contraindication of the acupuncture;
  • Patients with mental disease;
  • Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Treatment and study plan

Acupuncture Therapy

Device

Laparoscopic surgery

Procedure

Primary outcomes

  1. Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)

    Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

Secondary outcomes

  1. Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability

    Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

  2. Prostaglandin E2(PGE2) in blood

    Time frame: day 2,day 7 after surgery

  3. Estradiol(Female) in blood

    Time frame: day 2, day 7 after surgery

  4. Th1/Th2 in blood

    Time frame: day 2, day 7 after surgery

  5. 5-Hydroxytryptamine(5-HT) in blood

    Time frame: day 2,day 7 after surgery

  6. Histamine(HIS) in blood

    Time frame: day 2,day 7 after surgery

  7. Th17/Treg in blood

    Time frame: day 2, day 7 after surgery

  8. Testosterone(Male) in blood

    Time frame: day 2,day 7 after surgery

Sponsors and collaborators

Lead sponsor

Xiaonan Cui

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2016
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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