Postoperative ChemotherapyNCT07276932
Clinical Study of Acupoint Application on Relieving qi Deficiency and Constipation in Patients Undergoing Chemotherapy
A study testing Acupoint application and Routine treatment and nursing of constipation in people with Postoperative Chemotherapy and Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
4.1 Research Content 1. Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Chemotherapy, Chemotherapy
- What is being tested?
- Acupoint application and Routine treatment and nursing of constipation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of colorectal cancer
- Chemotherapy was performed after surgery
- Diagnosis of qi deficiency and constipation
- Age ≥18 years old
Who cannot join
- Clinical diagnosis of other digestive tract or anal organic diseases
- Observed with severe cardiac, hepatic, renal insufficiency or other complications
- Allergic constitution or allergy to a drug in constipation paste
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yan Yang, 0571-86993370, 2201031@zju.edu.cn
Yang, 2201031@zju.edu.cn
About this study
Official title: Clinical Study on Acupoint Application Based on the Theory of "State-target Syndrome Differentiation" in Relieving qi Deficiency and Constipation in Patients With Colorectal Cancer Undergoing Postoperative Chemotherapy
4.1 Research Content
- Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and traditional Chinese medicine prescription, analysis of meridian tropism of acupoints, Chinese herbal medicine taste and meridian tropism, etc., and multidisciplinary expert consultation. Through two rounds of Delphi expert letter consultation, the acupoint application scheme for deficiency and secret of CRC patients undergoing chemotherapy was determined.
- Randomized controlled trials were conducted to compare the effect of acupoint application scheme and conventional treatment in improving constipation symptoms, total clinical efficacy, and improving patient comfort rate in CRC patients undergoing chemotherapy.
Read more
4.2 Key problems to be solved Based on the theory of "state-target dialectics", the analysis of acupoints and traditional Chinese medicine prescriptions, the analysis of meridian tropism of acupoints, the flavor and meridian tropism of Chinese herbs are used to select Chinese herbs that moisten the intestine and relieve defecation, strengthen the central and qi, and explore the acupoint application to provide a basis for more effective application of acupoint application in the treatment of qi deficiency and constipation in patients with CRC chemotherapy, form a generalized integrated Chinese and western medicine diagnosis and treatment plan, and promote the development of integrated Chinese and western medicine.
4.3 Expected Goals
- Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.
- The flexible application of classic formula and scientific acupoint selection and sticking can effectively relieve qi deficiency and constipation in CRC patients undergoing chemotherapy, improve the total clinical efficacy and comfort of patients. It has been used in clinical practice and promoted to other medical institutions.
- Conditions
- Postoperative Chemotherapy, Chemotherapy
- Being tested
- Acupoint application, Routine treatment and nursing of constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupoint applicationDrug
- The traditional Chinese medicine patch was prepared according to the ratio of astragalus: tangerine peel: sesame seed seed: white mustard seed = 6:6:2:1, and an appropriate amount of honey was used to make the shape.
- Timing of application: finger time (6:30 am).
- Acupoint prescription: Zusanli (bilateral), Zhongwan (CV 12), Qihai (CV 6) and Guanyuan (CV 4).
- Location of acupoint: the patient went to the supine position or sitting position with knee flexion. Zusanli (Zusanli) is three cun below the outer knee of both lower limbs; Zhongwan (CV 12) is located from xiphoid process to navel midpoint. Qihai acupoint is located on the median line of the human abdomen, three transverse fingers down from the umbilicus. Location of Guanyuan point: 3 cun (four fingers) below the belly button.
- Treatment time and frequency: once a day, 2 hour
Routine treatment and nursing of constipationBehavioural
- Diet care: supplement adequate dietary fiber and adequate water intake.
- Defecation training: regular defecation training in the morning. Patients or their family members should massage the abdomen clockwise for more than 10 minutes every day to increase the amount of activity.
- Emotional nursing: explain disease-related knowledge, improve patients' understanding of constipation, relieve bad emotions in time, help patients build confidence and actively participate in treatment.
| Study group | Role | What they receive |
|---|---|---|
| Acupoint application + conventional treatment and nursing program | Experimental | Not described Receives: Drug: Acupoint application; Behavioral: Routine treatment and nursing of constipation |
| Routine treatment and nursing of constipation | Active comparator | Not described Receives: Behavioral: Routine treatment and nursing of constipation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nimodipine method was used to calculate the total symptom score of patients
Efficacy index =[(pre-treatment score - post-treatment score)/pre-treatment score]× 100%, which was divided into 4 grades: clinical cure, marked effect, effective and ineffective. Clinical recovery: the main symptoms and signs disappeared or basically disappeared, and the efficacy index was ≥ 95%. Marked efficacy: the main symptoms and signs were significantly improved, 70% ≤ efficacy index < 95%; Effective: the main symptoms and signs were significantly improved, 30% ≤ efficacy index < 70%; Ineffective: the main symptoms and signs were not significantly improved, or even aggravated, and the efficacy index was less than 30%.
Measured: Five days after the intervention
Constipation symptom assessment form
It was formulated by the Anorectal Surgery Group of Chinese Society of Surgery of Chinese Medical Association, and included six dimensions: defecation frequency, defecation time, defecation difficulty, stool character, abdominal distension, falling, incomplete and fullness. A 4-point scale was used to evaluate the severity of symptoms.The higher the score, the more severe the constipation symptoms.The minimum score was 0 and the maximum score was 18.
Measured: Before and after 5 days of intervention
Secondary outcomes (3)
Chinese version of Symptom Checklist for Constipation (PAC-SYM)
Developed by MaPi Research Trust in France, it has good reliability and validity and has been widely used in clinical practice. The questionnaire included 3 dimensions and 12 items, including stool shape, rectal and abdominal symptoms, etc. The severity of symptoms was evaluated using a 5-point scale. The higher the score, the more severe the patient's constipation symptoms. The lowest score was 0 and the highest score was 48.
Measured: Before and after 5 days of intervention
Constipation quality of life self-rating scale (PAC-QOL)
The Chinese version was developed by Mapi Research Trust, with 28 items in total, involving patients' physiology, social psychology, worry, satisfaction and other aspects (see Appendix 3). It can comprehensively measure the quality of life of patients with constipation, and objectively and truly reflect the patient's status, treatment satisfaction and acceptance. A higher score indicates a higher level of quality of life in patients with constipation. The lowest score was 28 and the highest score was 112.
Measured: Before the intervention and 5 days after the intervention
TCM syndrome rating scale of qi deficiency and constipation
The application was developed by Li Jinyue et al., which reflected the symptoms of TCM syndromes, including shortness of breath, defecation weakness, lack of breath and lazy speech, and sweating. According to the patient's description of the related symptoms, the degree of severity was evaluated and divided into four levels: none, mild, moderate, and severe, and scored 0, 1, 2, and 3 points respectively. The higher the score, the more severe the patient's qi deficiency and constipation symptoms. The lowest score was 0 and the highest score was 12.
Measured: Before the intervention and 5 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start16 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ChemotherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276932
- Sponsor's protocol ID
- 2025-0322
- Status last verified
- Jan 2025
- First submitted
- 17 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Acupoint Application Based on the Theory of "State-target Syndrome Differentiation" in Relieving qi Deficiency and Constipation in Patients With Colorectal Cancer Undergoing Postoperative Chemotherapy
- ClinicalTrials.gov ID
- NCT07276932
- Acronym / sponsor ID
- 2025-0322
- Conditions
- Postoperative Chemotherapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2025 (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.
4.1 Research Content
- Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and traditional Chinese medicine prescription, analysis of meridian tropism of acupoints, Chinese herbal medicine taste and meridian tropism, etc., and multidisciplinary expert consultation. Through two rounds of Delphi expert letter consultation, the acupoint application scheme for deficiency and secret of CRC patients undergoing chemotherapy was determined.
- Randomized controlled trials were conducted to compare the effect of acupoint application scheme and conventional treatment in improving constipation symptoms, total clinical efficacy, and improving patient comfort rate in CRC patients undergoing chemotherapy.
4.2 Key problems to be solved Based on the theory of "state-target dialectics", the analysis of acupoints and traditional Chinese medicine prescriptions, the analysis of meridian tropism of acupoints, the flavor and meridian tropism of Chinese herbs are used to select Chinese herbs that moisten the intestine and relieve defecation, strengthen the central and qi, and explore the acupoint application to provide a basis for more effective application of acupoint application in the treatment of qi deficiency and constipation in patients with CRC chemotherapy, form a generalized integrated Chinese and western medicine diagnosis and treatment plan, and promote the development of integrated Chinese and western medicine.
4.3 Expected Goals
- Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.
- The flexible application of classic formula and scientific acupoint selection and sticking can effectively relieve qi deficiency and constipation in CRC patients undergoing chemotherapy, improve the total clinical efficacy and comfort of patients. It has been used in clinical practice and promoted to other medical institutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint application + conventional treatment and nursing program | Experimental | Drug: Acupoint application, Behavioral: Routine treatment and nursing of constipation |
| Routine treatment and nursing of constipation | Active comparator | Behavioral: Routine treatment and nursing of constipation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of colorectal cancer
- Chemotherapy was performed after surgery
- Diagnosis of qi deficiency and constipation
- Age ≥18 years old
Key exclusion criteria (3 listed)
- Clinical diagnosis of other digestive tract or anal organic diseases
- Observed with severe cardiac, hepatic, renal insufficiency or other complications
- Allergic constitution or allergy to a drug in constipation paste
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 application1. The traditional Chinese medicine patch was prepared according to the ratio of astragalus: tangerine peel: sesame seed seed: white mustard seed = 6:6:2:1, and an appropriate amount of honey was used to make the shape. 2. Timing of application: finger time (6:30 am). 3. Acupoint prescription: Zusanli (bilateral), Zhongwan (CV 12), Qihai (CV 6) and Guanyuan (CV 4). 4. Location of acupoint: the patient went to the supine position or sitting position with knee flexion. Zusanli (Zusanli) is three cun below the outer knee of both lower limbs; Zhongwan (CV 12) is located from xiphoid process to navel midpoint. Qihai acupoint is located on the median line of the human abdomen, three transverse fingers down from the umbilicus. Location of Guanyuan point: 3 cun (four fingers) below the belly button. 5. Treatment time and frequency: once a day, 2 hour | Drug | Acupoint application + conventional treatment and nursing program |
| Routine treatment and nursing of constipation1. Diet care: supplement adequate dietary fiber and adequate water intake. 2. Defecation training: regular defecation training in the morning. Patients or their family members should massage the abdomen clockwise for more than 10 minutes every day to increase the amount of activity. 3. Emotional nursing: explain disease-related knowledge, improve patients' understanding of constipation, relieve bad emotions in time, help patients build confidence and actively participate in treatment. | Behavioural | Acupoint application + conventional treatment and nursing program, Routine treatment and nursing of constipation |
Primary outcome
The Nimodipine method was used to calculate the total symptom score of patients
Time frame: Five days after the intervention
Efficacy index =[(pre-treatment score - post-treatment score)/pre-treatment score]× 100%, which was divided into 4 grades: clinical cure, marked effect, effective and ineffective. Clinical recovery: the main symptoms and signs disappeared or basically disappeared, and the efficacy index was ≥ 95%. Marked efficacy: the main symptoms and signs were significantly improved, 70% ≤ efficacy index < 95%; Effective: the main symptoms and signs were significantly improved, 30% ≤ efficacy index < 70%; Ineffective: the main symptoms and signs were not significantly improved, or even aggravated, and the efficacy index was less than 30%.
Constipation symptom assessment form
Time frame: Before and after 5 days of intervention
It was formulated by the Anorectal Surgery Group of Chinese Society of Surgery of Chinese Medical Association, and included six dimensions: defecation frequency, defecation time, defecation difficulty, stool character, abdominal distension, falling, incomplete and fullness. A 4-point scale was used to evaluate the severity of symptoms.The higher the score, the more severe the constipation symptoms.The minimum score was 0 and the maximum score was 18.
3 secondary outcomes
Chinese version of Symptom Checklist for Constipation (PAC-SYM)
Time frame: Before and after 5 days of intervention
Constipation quality of life self-rating scale (PAC-QOL)
Time frame: Before the intervention and 5 days after the intervention
TCM syndrome rating scale of qi deficiency and constipation
Time frame: Before the intervention and 5 days after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupoint application and Routine treatment and nursing of constipation in people with Postoperative Chemotherapy and Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yang (0571-86993370, 2201031@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nimodipine method was used to calculate the total symptom score of patients (time frame: Five days after the intervention). The study lists 2 primary outcomes in all. 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 Dec 2025.