Condition category
Cancer
Date applied
22/05/2008
Date assigned
29/05/2008
Last edited
04/03/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ubc.ca/

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes