NCT03553355

Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cancer-related fatigue (CRF) is the most common and distressing symptom associated with tumor or cancer treatment that breast cancer survivors (BCS) experience.The investigators previously found the laser moxibustion was potentially efficacious for CRF; however, more rigorously designed study is needed to confirm its benefit. The primary aim of this study is to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on CRF. Secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing symptoms such as among BCS experiencing CRF.

Detailed description

The randomized, placebo-controlled, three-arm trial will be conducted to evaluate the efficacy of infrared laser moxibustion (ILM) and sham ILM (SILM) compared to waitlist control (WLC) for moderately to severely fatigued BCS. The two intervention groups will receive real/sham infrared laser moxibustion on four acupoints (e.g. ST36 (bilateral), CV4, and CV6) for 20 minutes each session for six weeks (two times per week). The primary endpoint is the change in fatigue scores from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aims are to compare the severity of comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere length) among the three groups.

Conditions

• Cancer-related Fatigue

Interventions

Type	Name	Description
DEVICE	Infrared Laser Moxibustion	We will use SX10-C1 laser moxibustion devices (Shanghai Wonderful Opto-Electrics Tech Co Ltd, Shanghai, China) for the ILM and SILM groups. Four laser probes will be synchronously aligned with 4 points (tST36 (bilateral), CV4, and CV6 acupoints) and we will irradiate each acupoint 2 cm away from the skin surface for 20 minutes. Each patient will receive this treatment twice per week for six weeks (12 sessions total).
DEVICE	Sham Infrared Laser Moxibustion	The sham laser moxibustion instrument appears to be identical as the real one.

Timeline

• Start date: 2018-06-20
• Primary completion: 2021-03-23
• Completion: 2021-07-27
• First posted: 2018-06-12
• Last updated: 2021-08-11

Locations

1 site across 1 country: China