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

NCT07276932 | Recruiting

• 1 other identifier: 2025-0322
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

4.1 Research Content

1. 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. 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.
3. 3.Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.
4. 4.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

Outcome Measures

Primary Outcomes (2)

• 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%.

  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.

  Before and after 5 days of intervention

Secondary Outcomes (3)

• Chinese version of Symptom Checklist for Constipation (PAC-SYM)

  Before and after 5 days of intervention

• Constipation quality of life self-rating scale (PAC-QOL)

  Before the intervention and 5 days after the intervention

• TCM syndrome rating scale of qi deficiency and constipation

  Before the intervention and 5 days after the intervention

Study Arms (2)

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

Interventions

Acupoint application 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

Acupoint application + conventional treatment and nursing program

Routine treatment and nursing of constipation 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.

Acupoint application + conventional treatment and nursing program; Routine treatment and nursing of constipation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of colorectal cancer
• Chemotherapy was performed after surgery
• Diagnosis of qi deficiency and constipation
• Age ≥18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Yan Yang

CONTACT

0571-86993370; 2201031@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 11, 2025
• Study Start: July 16, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-01

Locations

CN (1)