A Phase 2 interventional study of Modified Xiang Bei Yang Rong Tang and Placebo in Cancer, Fatigue and Cognitive Impairment, sponsored by National University of Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by National University of Singapore · Phase 2, Interventional, and Treatment
This study is a phase 2, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of a Traditional Chinese Medicine decoction, the modified Xiang Bei Yang Rong Tang, in alleviating cancer related fatigue in cancer survivors.
Cancer-related fatigue (CRF) is a distressing, persistent and subjective sense of physical, emotional, or cognitive tiredness related to cancer or its treatment. Currently there is a lack of effective conventional pharmacological intervention for treating this condition. Traditional Chinese Medicine (TCM) could be alternative therapy for managing CRF.
This study is a phase 2, randomized, double-blinded, placebo-controlled trial to examine the efficacy and safety of a TCM decoction, the modified Xiang Bei Yang Rong Tang (XBYRT) in alleviating CRF in cancer survivors. Study participants recruited from National Cancer Centre Singapore (NCCS) will be randomized to receive either the XBYRT or placebo decoction. Participants will take their assigned decoction daily for a duration of 8 weeks and will be assessed using patient reported outcome (PRO) questionnaires. PROs used are the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ 30) for QOL, the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) for fatigue and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Version 3 for cognitive abilities. The changes in scores measured by these assessment tools will be compared between the XBYRT intervention and placebo groups. Blood biomarkers such as inflammatory cytokines, mitochondrial DNA and oxidative stress markers will also be evaluated in the study participants. Additionally, adverse events or serious adverse events in participants will be monitored for safety.
Results from this study will provide a better understanding on the role of TCM in managing CRF.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's planned enrollment of 80 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules
Other: Modified Xiang Bei Yang Rong Tang
Participants assigned to receive placebo (contains 5% of XBYRT) granules
Other: Placebo
Modified Xiang Bei Yang Rong Tang is a combination of 15 herbal components and it is available in granules form to be dissolved in hot water for consumption
Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler
Difference in Global Health Status (GHS) score
Difference in Global Health Status (GHS) score from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between XBYRT interventional and placebo arms from baseline to 8 weeks after baseline. The GHS scale ranges in score from 0-100. A higher score represents a better quality of life
Time frame: 8 weeks from baseline
Difference in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores
Difference in MFSI-SF scores between XBYRT interventional and placebo arms. THE MFSI-SF consists of 30 items and has 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigour. The MFSI-SF measures different dimensions of fatigue, which can be combined to obtain an overall score. A higher score represents worse fatigue (total score ranges from -24 to 96)
Time frame: 4, 8 and 10 weeks from baseline
Difference in Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 scores
Difference in FACT-Cog V3 scores between XBYRT interventional and placebo arms. FACT-Cog v.3 will be used to assess subjective cognitive disturbances. These disturbances are assessed via 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency (total score ranges from 0-148). A lower score represents worse cognitive function.
Time frame: 4, 8 and 10 weeks from baseline
Incidence of adverse events
Adverse events reported according to the Adverse events Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: baseline, and 4, 8 and 10 weeks from baseline
Difference in EORTC QLQ-C30 version 3.0 Functional and Symptom scale scores
Difference in EORTC QLQ-C30 scores between XBYRT interventional and placebo arms. The EORTC QLQ-C30 consists of 30 items across functional domains, symptoms domains and a global health status domain. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of problems.
Time frame: 4, 8 and 10 weeks from baseline
Mitochondrial DNA (mtDNA) content
Mitochondrial DNA (mtDNA) content reduction in XBYRT interventional and placebo arms
Time frame: baseline, 4, 8 and 10 weeks from baseline
Inflammatory cytokines : C reactive protein (CRP) and cytokines TNF-α, IL-1β, IL-6, and IL-8
Plasma inflammatory cytokine levels in XBYRT interventional and placebo arms
Time frame: baseline, 4, 8 and 10 weeks from baseline
Oxidative stress markers : malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px)
Plasma oxidative stress markers levels in XBYRT interventional and placebo arms
Time frame: baseline, 4, 8 and 10 weeks from baseline
Plan to share: No
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University of Singapore