Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

NCT03162133 | Completed

• 1 other identifier: 20170217
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months. All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control. Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.

Conditions

Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

Keywords

Breast Cancer; Aromatase Inhibitor Therapy; Baduanjin Exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Quality of Life (QoL) at 3 months

  European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)

  at baseline and 3 months

Secondary Outcomes (14)

• Change from Baseline IL-6 at 3 months

  at baseline and 3 months

• Change from Baseline Fatigue at 3 months

  at baseline and 3 months

• Change from Baseline sleep quality at 3 months

  at baseline and 3 months

• Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months

  at baseline and 3 months

• Change from Baseline Symptoms of climacteric syndrome at 3 months

  at baseline and 3 months

Study Arms (2)

Exercise group

EXPERIMENTAL

After completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week. The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China. Two senior Baduanjin teachers from Guangzhou Sports University conducted the training.

Other: Baduanjin exercise

Waiting list Control group

EXPERIMENTAL

Participants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise. After their post-assessment they were able to attend the Baduanjin classes.

Other: Baduanjin exercise

Interventions

Baduanjin exercise OTHER

Exercise group; Waiting list Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment
• Taking an AI (aromatase inhibitors )，and had been receiving an AI for at least 6 months

You may not qualify if:

• A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer
• With exercise contraindications：chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse
• Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months
• Women reporting 5 hours or more of vigorous physical activity per week

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Guangzhou Sport University: collaborator

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kun Wang

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 22, 2017
• Study Start: November 10, 2016
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2018
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CN (1)