Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04749381
Other study ID # PKUCH-R06
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2020
Est. completion date February 20, 2023

Study information

Verified date February 2021
Source Beijing Cancer Hospital
Contact Nan Chen, M.D.;Ph.D
Phone +86 18911956939
Email chennanpku@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.


Description:

The hypothesis is that TCM can decrease the postoperative complications for rectal cancer. So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo. The intervention will be described below. Primary endpoint is postoperative complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date February 20, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Signed written consent form; - Age from 18 to 75 years old; - Pathological diagnosis as rectal adenocarcinoma; - undergo laparoscopic curative surgery; - Patients' TCM syndrome accords with thoses of spleen deficiency syndrome; Exclusion Criteria: - Patients undergo non-curative surgeries; - Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control; - Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment; - Women who are pregnant or breastfeeding; - Participants have mental illness or have difficulty in language communication and are unable to complete the study; - Participants could not cooperate with this researcher for other reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
acupoint with TCM
The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
acupoint with placebo
The placebo acupoint application was made of black beans and honey, which shares the similar shape and smell of the experiment group, applied at the same acupoints.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications Rates of the complications after curative surgery from operation to 30 days after operation
Secondary recovery of urinary function The rates of urinary retention after removal of urinary catheter from removal of urinary catheter to 30 days after operation
Secondary Recovery of fart and bowel function The time of the first tart and first defecation after operation in days 7 days after operation
Secondary The European Organization of Quality of Life Questionnaire-colorectal-29 Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer. 30 days after operation
Secondary Changes of TCM symptoms Changes of traditional Chinese medicine symptoms: all symptoms were recorded by 10 simple questions and then will be categorized in 4 different groups. The aim of study tries to show the relationship with TCM application with the symptoms. 30 days after operation
Secondary Length of hospital stay Time of hospital stay in days 30 days after operation
See also
  Status Clinical Trial Phase
Recruiting NCT06380101 - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) N/A
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Recruiting NCT04323722 - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting NCT01347697 - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer N/A
Recruiting NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer Phase 3
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Not yet recruiting NCT03520088 - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS N/A
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting NCT03283540 - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Recruiting NCT05914766 - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer N/A
Recruiting NCT04852653 - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Terminated NCT02933944 - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer Phase 1
Active, not recruiting NCT02438839 - Curative Chemoradiation of Low Rectal Cancer