Clinical trial NCT05409352: Self-administered Acupressure to Improve Cancer-related Fatigue Among Cancer Patients Undergoing Chemotherapy
Official title: Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Fatigue
Acupressure
Exercise
Keywords: cancer
fatigue
acupressure
exercise
chemotherapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Cancer-related fatigue (CRF) is recognized as the most frequently reported and distressing symptom among cancer patients. CRF is particularly prevalent in patients undergoing chemotherapy, reported to affect 82-100% of such patients, which in some cases may lead to treatment interruption or discontinuation. If CRF is left untreated during chemotherapy, patients are more likely to have clinically significant CRF that persists for months and years after the treatment. CRF has pervasive impact on a patient's mood, ability to perform daily activities, social relationships, and quality of life (QoL). It also imposes significant financial burden by limiting a patient's ability to work. CRF has been shown to be a risk factor of cancer recurrence and shortened survival. In view of its high prevalence and negative impact, combined with growing survival rates, CRF can be considered as a major public health concern.

Aerobic exercise is the most recommended non-pharmacological strategy for CRF, but it has practical limitations due to a number of barriers to exercise during cancer treatment. Self-administered acupressure is emerging as a promising new strategy for reducing CRF in post-treatment disease-free cancer survivors, but has not been tested rigorously among cancer patients receiving chemotherapy. Both exercise and acupressure are inexpensive and safe self-management strategies that can alleviate CRF and co-occurring cancer symptoms, but as acupressure demands less energy, it may thus be acceptable for a wider range of patients undergoing chemotherapy and experiencing CRF. While previous RCTs on acupressure have focused on post-treatment cancer patients, studies targeting patients undergoing cancer treatment are scarce. A rigorously designed RCT of self-administered acupressure among patients receiving chemotherapy is warranted. To date, no study has examined the equivalence of self-administered acupressure and exercise for reducing CRF. Knowledge of the equivalence of aerobic exercise and acupressure for relieving CRF has important clinical implications that could allow practitioners to target recommendations on the basis of patient preference for a particular type of self-care management.

The primary aim of this study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), QoL, cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention.

Eligibility criteria: Inclusion Criteria:

1. aged 18 or above
2. with a diagnosis of breast cancer
3. scheduled to commence their first cycle of outpatient adjuvant chemotherapy
4. have an Eastern Cooperative Oncology Group performance status of 0 or 1
5. 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)
6. written informed consent

Exclusion Criteria:

1. have received/self-administered acupressure or acupuncture in the previous 3 months
2. have engaged in \>90 min of moderate intensity aerobic exercise per week in the previous 3 months
3. are pregnant or lactating
4. have any injury or ulcers around the acupoints
5. unable to communicate in Cantonese, Mandarin, or English

Primary outcomes:
measure: Fatigue levels
timeFrame: post-intervention (the week after the 12-week intervention)
measure: Fatigue levels
timeFrame: one month after the end of all chemotherapy cycles
Secondary outcomes:
measure: Self-reported sleep quality
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
measure: Health-related quality of life (QoL)
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
measure: Self-reported activity levels
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
measure: Return to work
timeFrame: one month after the end of all chemotherapy cycles
measure: Chemotherapy completion
timeFrame: one month after the end of all chemotherapy cycles
measure: Objective measure of sleep quality and activity levels
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
measure: Adherence
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
measure: Cognitive impairment
timeFrame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: