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Clinical Study for Chinese Compound Changjitai Combined With Ear Acupuncture on Cancer Related Fatigue of Postoperative Colorectal Carcinoma

Clinical Study for Chinese Compound Changjitai Combined With Ear Acupuncture on Cancer Related Fatigue of Postoperative Colorectal Carcinom

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025051
Enrollment
Unknown
Registered
2019-08-09
Start date
2019-08-07
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

cancer related fatigue of Postoperative Colorectal carcinoma

Interventions

experimental group :Changjitai Combined with Ear Acupuncture
control group:Gushen combined with Ear Acupuncture for Non-meridian and Non-acupoint Therapy

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. It meets the diagnostic criteria of colorectal cancer and belongs to the stable stage of postoperation. According to The Newly Organized Criteria of Diagnosis for the Common Malignant Tumor, the diagnosis was made on the basis of surgical pathology. Postoperative stabilization refers to the period of 5 years after a week later of the end of chemotherapy and/or radiotherapy for colorectal cancer. 2. The diagnostic criteria that meet the cancer-induced fatigue. Using the CRF diagnostic criteria presented at the 10th international conference on the revision of the classification of diseases (ICH-10), fatigue symptoms were repeated and persisted for more than two weeks, accompanied by the following five or more than five symptoms: (1)Weak feeling or physically heavy; (2)inattention; (3) lack of passion, low mood, lack of energy; (4)insomnia or somnolence; (5)unable to recover energy after sleeping; (6)have difficult in acting; (7)appear emotional reactions like sad, irritable, frustration and so on; (8)can not do daily activities; (9)hypomnesis of short-term memory; (10)fatigue symptoms persist for several hours and can not anesis after activities. 3. Meet the diagnostic criteria of syndrome of liver-depression and spleen-deficiency in TCM. According to the The Guiding Principles for Clinical Research of New Chinese Medicine, three primary symptoms (gastral cavity or distending pain in hypochondrium) are necessary for the diagnosis of liver-depression and spleen-deficiency, or two primary symptoms (gastral cavity or distending pain in hypochondrium) and two secondary symptoms. Primary symptoms: gastral cavity or distending pain in hypochondrium, abdominal distension, eating less and nerveless, difficult defecation secondary symptoms: depressed or irritable, sighed, hardly aerofluxus, abdominal pain and diarrhea, pain relief after diarrhea, coating on the tongue is white or greasy, pulse string is fine. 4. The age of the people who accept the testing: 40 to 79 years, no gender preference. 5. The patients are informed and consented.

Exclusion criteria

Exclusion criteria: 1. Patients with terminal colorectal cancer or metastatic colorectal cancer. 2. Patients receiving antineoplaston such as chemotherapy, radiotherapy and biotherapy. 3. The expected lifetime less than six months, and patients with other serious diseases of heart, liver, kidney, digestion, respiration and the blood system or chronic diseases that affect the judgment of efficacy. 4. With cognitive disorder speech defectsdifficult to cooperate with investigators. 5. Using TCM health care products with characteristics of tonifying qi and enriching the blood at the same time, affecting the judgment of efficacy.

Design outcomes

Primary

MeasureTime frame
the Revised Piper's Fatigue Scale, RPFS;TCM Syndrome Score of Liver Depression and Spleen Deficiency Syndrome;T lymphocyte subsets and natural killer cells;carcinoembryonic antigen;Alpha fetoprotein;carbohydrate antigen 724;The tumor lesion;

Secondary

MeasureTime frame
Routine blood test;routine urine test;routine stool examination;electrocardiogram;liver function test;renal function test;

Countries

China

Contacts

Public ContactLi Han

Huadong Hospital Affiliated to Fudan University

tcmhan@163.com+86 13917377143

Outcome results

None listed

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