Study of Effects of Dao-yin Exercise on the Patients With Breast Cancer Post Operation and Receiving Adjuvant Chemotherapy

NCT07262099 | Completed

• 1 other identifier: TSGH-C106-020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective registration of a study that evaluated whether a traditional Dao-yin (mind-body exercise), called Shangshou Dao-yin, could improve sleep quality, Chinese medicine body constitution, and quality of life in breast cancer patients receiving adjuvant chemotherapy. A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned to either a Dao-yin exercise group (72 participants) or a control group (78 participants) based on their preference. The exercise group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherapy, while the control group received standard care only. After withdrawals, 138 participants completed the final evaluation (66 in the Dao-yin group and 72 in the control group). Sleep quality, body constitution (BCQ), quality of life (EORTC), and chemotherapy-related adverse effects were assessed during treatment and three weeks after chemotherapy completion. The findings may help determine whether Shangshou Dao-yin can reduce sleep disturbance and enhance well-being during cancer treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30)

  Quality of life was assessed using the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30). Scores were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)

  Baseline to 3 weeks after completion of chemotherapy

• Change in Breast Cancer-Specific Quality of Life (EORTC Breast Cancer-Specific Quality of Life Questionnaire; QLQ-BR23)

  Breast cancer-specific quality of life was measured using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). All subscales were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)

  Baseline to 3 weeks after completion of chemotherapy

Secondary Outcomes (2)

• Change in Body Constitution (Body Constitution Questionnaire; BCQ)

  Baseline to 3 weeks after completion of chemotherapy

• Chemotherapy-related Adverse Events (CTCAE v4.0)

  Baseline to 3 weeks after completion of chemotherapy

Other Outcomes (4)

• Sleep Quality (Pittsburgh Sleep Quality Index; PSQI)

  Baseline to 3 weeks after completion of chemotherapy

• Anxiety (Beck Anxiety Inventory; BAI)

  Baseline

• Beck Depression Inventory-II; BDI-II

  Baseline

Study Arms (2)

Shangshou Dao-yin Group

EXPERIMENTAL

Participants practiced Shangshou Dao-yin, a traditional mind-body exercise, for 20 minutes daily throughout the course of adjuvant chemotherapy. A standardized instructional video was provided to guide home or hospital practice.

Behavioral: Shangshou Dao-yin

Control Group

NO INTERVENTION

Participants received standard medical care during chemotherapy without any structured exercise intervention.

Interventions

Shangshou Dao-yin BEHAVIORAL

Participants practiced Shangshou Dao-yin, a traditional Daoist mind-body exercise consisting of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The exercise features gentle, rhythmic movements combined with natural breathing and mental focus, and requires no equipment or special space, making it suitable for patients undergoing chemotherapy. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube), was used to guide self-practice. Participants performed 20 minutes of Shangshou Dao-yin per day throughout the entire course of adjuvant chemotherapy, either at home or in the hospital.

Shangshou Dao-yin Group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed Stage I, II, or III breast cancer with surgical tumor removal followed by adjuvant chemotherapy.
• Age ≥ 20 years.
• Ability to walk independently without movement restrictions.
• Able to communicate in Mandarin or Taiwanese.
• Provided written informed consent.

You may not qualify if:

• Regularly practicing Tai Chi or other mind-body exercises at the time of enrollment.
• Pre-existing chronic illnesses or symptoms that may interfere with evaluation of chemotherapy-related side effects (e.g., chronic diarrhea, neuropathy, heart failure, thromboembolic disease, chronic pulmonary or renal disease, alopecia).
• Pregnancy.
• Severe psychiatric illness (e.g., schizophrenia, major depressive disorder).

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taipei City, 11490, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Attending Physician, Department of Traditional Chinese Medicine

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: January 13, 2017
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)