Rectal CancerPhase 2RCTNCT04749381
The Role of TCM on ERAS of Rectal Cancer Patients
A Phase 2 study testing acupoint with TCM in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- acupoint with TCM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2020to 20 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Nan Chen, M.D.;Ph.D., +86 18911956939, chennanpku@126.com
Aiwen Wu, M.D
About this study
Official title: The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
Read the detailed 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.
- Conditions
- Rectal Cancer
- Being tested
- acupoint with TCM, acupoint with placebo
- Keywords
- ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life
- Medical subject headings
- Rectal Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint with TCMCombination product
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 placeboCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| TCM group | Experimental | Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine. Receives: Combination Product: acupoint with TCM |
| Control group | Placebo comparator | Rectal cancer patients randomized to this group will have acupoint application with placebo . Receives: Combination Product: acupoint with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Rates of the complications after curative surgery
Measured: from operation to 30 days after operation
Secondary outcomes (5)
recovery of urinary function
The rates of urinary retention after removal of urinary catheter
Measured: from removal of urinary catheter to 30 days after operation
Recovery of fart and bowel function
The time of the first tart and first defecation after operation in days
Measured: 7 days after operation
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.
Measured: 30 days after operation
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.
Measured: 30 days after operation
Length of hospital stay
Time of hospital stay in days
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start28 Sep 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled are randomized into acupoint application group and placebo acupoint application group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwen Wu, Peking University Cancer Hospital & Institute
- Investigators
- Aiwen Wu, M.D., Principal investigator, Peking University Cancer Hospital & InstituteXiaoqiang Jia, M.D.;Ph.D, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749381
- Sponsor's protocol ID
- PKUCH-R06
- Acronym
- RCT
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04749381
- Acronym / sponsor ID
- RCT / PKUCH-R06
- Conditions
- Rectal Cancer
- Keywords
- ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled are randomized into acupoint application group and placebo acupoint application group
| Arm | Type | Receives |
|---|---|---|
| TCM group | Experimental | Combination Product: acupoint with TCMRectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine. |
| Control group | Placebo comparator | Combination Product: acupoint with placeboRectal cancer patients randomized to this group will have acupoint application with placebo . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupoint with TCMThe acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints. | Combination product | TCM group |
| acupoint with placeboThe 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. | Combination product | Control group |
Primary outcome
Postoperative complications
Time frame: from operation to 30 days after operation
Rates of the complications after curative surgery
5 secondary outcomes
recovery of urinary function
Time frame: from removal of urinary catheter to 30 days after operation
Recovery of fart and bowel function
Time frame: 7 days after operation
The European Organization of Quality of Life Questionnaire-colorectal-29
Time frame: 30 days after operation
Changes of TCM symptoms
Time frame: 30 days after operation
Length of hospital stay
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiwen Wu, M.D. principal investigator
Peking University Cancer Hospital & Institute
Xiaoqiang Jia, M.D.;Ph.D principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupoint with TCM in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Chen, M.D.;Ph.D (+86 18911956939, chennanpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: from operation to 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.