Contact information
Type
Scientific
Primary contact
Dr Jean-Paul Collet
ORCID ID
Contact details
Child and Family Research Institute
Ctr for Applied Health Res & Evaluation
Room E414A
4480 Oak Street
Vancouver
British Columbia
V6H 3V4
Canada
+1 604 875 3130
jcollet@cw.bc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-73503
Study information
Scientific title
The effectiveness of traditional Chinese herbal medicine and Tai Chi on improving quality of life of cancer patients: a pilot randomised clinical trial
Acronym
Study hypothesis
To examine the feasibility of conducting a large Canadian trial aimed at assessing the effectiveness of traditional Chinese herbal medicine (with specially tailored formulas) and Tai Chi on improving cancer patients' quality of life (QoL).
Hypothesis:
Patients receiving Chinese herbal medicine or Tai Chi will have more energy, more appetite and more overall quality of life than patients exposed to placebo or light physical exercise.
Please note that as of 04/03/2009 the anticipated start and end dates in this record were amended. The previous dates are as follows:
Initial anticipated start date: 30/06/2008
Initial anticipated end date: 30/12/2008
Please also note that at this time, the disease was amended from non-small cell lung cancer to colorectal cancer.
Ethics approval
University of British Columbia (UBC) BC Cancer Agency (BCCA) Research Ethics Board approved on the 5th April 2007 (ref: H06-03861); most recent BC Cancer REB and NHPD approval (change of the study population) received in January 2009.
Study design
Single-centre, factorial randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal cancer/fatigue, nausea, vomiting, anorexia/Chinese medicine for improving cancer patients' quality of life
Intervention
Factorial randomised controlled trial with two factors being herbal treatment (double-blinded, placebo-controlled) and Tai Chi exercise (group mild exercise-controlled).
The experimental interventions are:
1. Tailored TCM herbal decoction (twice daily for three months), based on 58 TCM herbs/products (added 04/03/2009)
2. Tai Chi exercise
The control interventions are:
1. Placebo decoction (twice daily for three months)
2. Control for Tai Chi group intervention is group mild exercise
Contact for public queries:
Nataliya Yuskiv, IMG, MPH
Study Coordinator
Applied Health Research and Evaluation
4480 Oak Street, Room E414A
Vancouver, British Columbia
V6H 3V4, Canada
Tel: +1 604 875 2000 ext. 5322
Cell: +1 604 250 1918
Fax: +1 604 875 3124
Email: nyuskiv@cw.bc.ca
Intervention type
Drug
Phase
Not Applicable
Drug names
Tailored TCM herbal decoction
Primary outcome measure
Primary outcome:
The feasibility as assessed through several factors, such as co-interventions, percentage of participation and withdrawal/non-compliance, preparing decoction/placebo and keeping blinding, the possibility to stratify, reasons for not participating, male/female difference regarding compliance and participation.
Primary clinical outcome: Quality of life
Primary outcome measuring time point: baseline, monthly, three months post-intervention
Secondary outcome measures
1. Fatigue
2. Nausea and vomiting
3. Anorexia
4. Insomnia
5. Anxiety and depression
Secondary outcome measuring time point: except for anxiety and depression which will be measured at baseline and the end of third month, the rest will be measured at baseline and monthly.
Overall trial start date
01/01/2009
Overall trial end date
30/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Amended 04/03/2009:
Point two of the inclusion criteria has been amended as follows:
2. Participant has been diagnosed with colorectal cancer
Initial information at time of registration:
1. Male or female participants greater than or equal to 18 years
2. Participant has been diagnosed with non-small cell lung cancer
3. Participant has completed chemotherapy treatments
4. Participant is experiencing fatigue, anorexia, or uncontrolled nausea or vomiting
5. Participant has enough strength to perform Tai Chi and mild exercises (Eastern Cooperative Oncology Group [ECOG] Performance Status 0,1,or 2)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
Amended 04/03/2009:
1. Severe allergy to herbs, plants or plant products
2. Severe diabetes, severe heart failure, liver failure, kidney failure or any severe concomitant conditions that could affect the follow-up or quality of life
3. Taking any drug that potentially increases the risk of bleeding
4. Pregnant or planning to get pregnant in the following three months
5. Breastfeeding or planning to breast feed in the following three months
6. Severe anaemia (haemoglobin less than 9 g/dL)
7. Cancer has spread to the long bones or spine
8. Exposure to TCM treatment within the last 2 weeks
9. Practicing Tai Chi exercises within the last months
10. Difficulty understanding the consent form
Initial information at time of registration:
1. Allergy to herbs, plants or plant products
2. Severe diabetes, severe heart failure, liver failure, kidney failure or any severe concomitant conditions that could affect the follow-up or quality of life
3. Pregnant or planning to get pregnant in the following three months
4. Breastfeeding or planning to breast feed in the following three months
5. Severe anaemia (haemoglobin less than 9 g/dL)
6. Cancer has spread to the bones
7. Already on TCM treatment
8. Difficulty understanding the consent form
Recruitment start date
01/01/2009
Recruitment end date
30/01/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Child and Family Research Institute
Vancouver, British Columbia
V6H 3V4
Canada
Sponsor information
Organisation
University of British Columbia (Canada)
Sponsor details
2075 Wesbrook Mall
Vancouver
British Columbia
V6T 1Z1
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73503)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Abstracts from scientific meetings:
1. Collet JP, Xu W, Shapiro S, MacDonald N, Li P, Chen J. Clinical evaluation of Traditional Chinese Medicine: methodological issues and solutions. Nov 23-25, 2006. 2006 World Congress on Chinese Medicine, Hong Kong.
2. Collet JP, Chen J, Li P, Xu W. Developing a web based electronic adverse event recording system for assessing the safety of Chinese herbal medicine. Nov 23-25, 2006. 2006 World Congress on Chinese Medicine, Hong Kong.
3. Collet JP, Xu W, Shapiro S. TCM Strategic development: importance of pragmatic trials in the evaluation process. Nov 23-25, 2006. 2006 World Congress on Chinese Medicine, Hong Kong.
4. Collet JP, Xu W, Chen J, Chung M, Klink R, Shapiro S, Macdonald N, Lam S. Is it possible to evaluate the practice of traditional medicine in Canada? 3rd Sickkids Foundation Forum, May 4, 2007. Can J Clin Pharmacol 2007, 14(2):e92.