Colorectal cancer/fatigue, nausea, vomiting, anorexia/Chinese medicine for improving cancer patients' quality of life Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Factorial randomised controlled trial with two factors being herbal treatment (double-blinded, placebo-controlled) and Tai Chi exercise (group mild exercise-controlled).
The experimental intervention
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed