Traditional Chinese medicine (TCM) for cancer
| ISRCTN | ISRCTN70448213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70448213 |
| Secondary identifying numbers | MCT-73503 |
- Submission date
- 22/05/2008
- Registration date
- 29/05/2008
- Last edited
- 04/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jean-Paul Collet
Scientific
Scientific
Child and Family Research Institute
Ctr for Applied Health Res & Evaluation, Room E414A
4480 Oak Street
Vancouver, British Columbia
V6H 3V4
Canada
| Phone | +1 604 875 3130 |
|---|---|
| jcollet@cw.bc.ca |
Study information
| Study design | Single-centre, factorial randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2009 |
| Completion date | 30/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/01/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Child and Family Research Institute
Vancouver, British Columbia
V6H 3V4
Canada
V6H 3V4
Canada
Sponsor information
University of British Columbia (Canada)
University/education
University/education
2075 Wesbrook Mall
Vancouver, British Columbia
V6T 1Z1
Canada
| Website | http://www.ubc.ca/ |
|---|---|
"ROR" |
https://ror.org/03rmrcq20 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73503)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
