Clinical Study of Acupoint Application on Relieving qi Deficiency and Constipation in Patients Undergoing Chemotherapy

NCT ID: NCT07276932

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2027-12-31

Brief 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 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.

2. 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

1. Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acupoint application + conventional treatment and nursing program

Group Type: EXPERIMENTAL

Acupoint application

Intervention Type: DRUG

1. 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

Routine treatment and nursing of constipation

Intervention Type: BEHAVIORAL

1. 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.

Routine treatment and nursing of constipation

Group Type: ACTIVE_COMPARATOR

Routine treatment and nursing of constipation

Intervention Type: BEHAVIORAL

1. 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.

Interventions

Acupoint application

1. 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

Intervention Type: DRUG

Routine treatment and nursing of constipation

1. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of colorectal cancer

2. Chemotherapy was performed after surgery

3. Diagnosis of qi deficiency and constipation

4. Age ≥18 years old

Exclusion Criteria

1. Clinical diagnosis of other digestive tract or anal organic diseases

2. Observed with severe cardiac, hepatic, renal insufficiency or other complications

3. Allergic constitution or allergy to a drug in constipation paste

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Yang

Role: CONTACT

2201031@zju.edu.cn

0571-86993370

Facility Contacts

Yan Yang

Role: primary

2201031@zju.edu.cn

0571-86993370

Yang

Role: backup

2201031@zju.edu.cn

Other Identifiers

2025-0322

Identifier Type: -

Identifier Source: org_study_id