An interventional study of Acupuncture and standard care (ASC) and Sham acupuncture and standard care (SSC) in Advanced Cancer, sponsored by The University of Hong Kong. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
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Exclusion Criteria:
Traditional manual acupuncture with standard care (ASC) will be provided. Subjects in the ASC group will receive 9 sessions of acupuncture and standard care for 3 weeks. A semi-standardized acupuncture treatment protocol (combined fixed acupoints with additional acupoints by symptom differentiation) will be employed. The fixed acupuncture points including, Guanyuan (CV4), Xuanzhong(GB39), Sanyinjiao (SP6), Yinlingquan (SP9), Zusanli (ST36), Yingtang (EX-HN3), Baihui (GV20), and Qihai (CV6) will be used in every session.
Other: Acupuncture and standard care (ASC)
Sham acupuncture plus standard care (SSC) will be provided. Subjects in the SSC group will receive 9 sessions of sham acupuncture and standard care for 3 weeks. The Streitberger sham acupuncture will be employed. The selection of acupoints is the same as ASC.
Other: Sham acupuncture and standard care (SSC)
Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks.
Other: Standard care (SC)
A semi-standardized treatment protocol and standard care will be employed.
Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.
Standard care will be employed.
Change of the symptom improvments
The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
Time frame: Change from baseline score at 3 weeks
EORTC QLQ-C15-PAL
The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL)
Time frame: weeks 0, 3, 7 and 11
Numeric Rating Scale
The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)
Time frame: weeks 0, 3, 7 and 11
Fatigue
The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue.
Time frame: weeks 0, 3, 7 and 11
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression.
Time frame: weeks 0, 3, 7 and 11
The Insomnia Severity Index
The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28.
Time frame: weeks 0, 3, 7 and 11
Symptom improvments
The Edmonton Symptom Assessment System (ESAS) consists of 9 common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
Time frame: weeks 0, 1, 2, 7 and 11
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong