Clinical trial NCT01374100: Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy
Official title: Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Cancer of the Gastrointestinal Tract
Keywords: Qigong
Complementary Medicine
Exercise
Traditional Chinese Medicine
Meditation
Standard Exercise
Chemotherapy
Advanced cancer
Quality of Life
Functional Assessment of Cancer Therapy
Hospital Anxiety and Depression Scale
Anxiety
Depression
Cancer Nutrition-Rehabilitation Program
Edmonton Symptom Assessment Scale
Simmonds Functional Assessment
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2011-06-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.

Detailed description: As per summary above

Eligibility criteria: Inclusion Criteria:

1. A pathologically (histological or cytological) confirmed clinical diagnosis of non-small cell lung cancer (NSCLC) or GI cancer
2. Stage 3 or 4 disease and eligible for anti-cancer treatment
3. Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology Group-Performance Status
4. Life expectancy estimated at \> 4 months
5. Age 18 years or older
6. Willing and able to provide informed consent
7. Must be approved for participation by the oncology treatment team
8. Able to communicate in French or English

Exclusion Criteria:

1. Contraindication to exercise as determined by the oncology treatment team
2. Severe cardiac or neuro-muscular/skeletal disease
3. Engaging in interventions to address anxiety or depressive symptoms
4. Brain metastases
5. Active psychiatric conditions
6. Pregnant or breast-feeding mothers

Primary outcomes:
measure: Change in Depression and Anxiety
timeFrame: 6 weeks
measure: Change in Quality of Life (QoL)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in functional capacity
timeFrame: 6 weeks
measure: Change in cancer Symptoms
timeFrame: 6 weeks
measure: Program Satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill, Cancer Nutrition Rehabilitation Program
name: Thomas Jagoe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderbyl BL, Mayer MJ, Nash C, Tran AT, Windholz T, Swanson T, Kasymjanova G, Jagoe RT. A comparison of the effects of medical Qigong and standard exercise therapy on symptoms and quality of life in patients with advanced cancer. Support Care Cancer. 2017 Jun;25(6):1749-1758. doi: 10.1007/s00520-017-3579-x. Epub 2017 Jan 19.