Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• aged 18 or above

• with a diagnosis of breast cancer

• scheduled to commence their first cycle of outpatient adjuvant chemotherapy

• have an Eastern Cooperative Oncology Group performance status of 0 or 1

• screened as no contraindications for exercise based on a pre-exercise safety assessment (including aspects of blood results, cardiorespiratory signs and symptoms, metastasis, and variations in cognitive functions)

• written informed consent

Locations
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Denise Shuk Ting Cheung, PhD
denisest@hku.hk
39176673
Backup
Sheung Yiu Chan, MNurs
chansyc@hku.hk
39176966
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 138
Treatments
Experimental: Self-administered acupressure
The entire intervention will last 12 weeks, including a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained traditional Chinese medicine practitioner. Participants will be instructed to perform self-acupressure on the acupoints according to individualized protocol once a day. Participants will be instructed to maintain self-practice after the intervention.
Active_comparator: Aerobic exercise
The 12-week aerobic exercise program consists of a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained exercise specialist. Participants will be advised to perform aerobic exercise of moderate intensity 3 times per week for 30 minutes each time. Accumulating 90 min of exercise per week through more frequent short bouts (e.g. 10-20 min daily) are allowed during the first week of each chemotherapy cycle due to increased symptom burden. Participants will be instructed to maintain self-practice after the intervention.
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov