Other Gynecological Cancers, Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Ovarian Cancer, Gynecological Malignancies, Chemotherapy, Tai-chi, Qigong, Fatigue, Quality of life, Sleep disturbance
Brief summary
Oncologic patients often report increased fatigue during and after chemotherapy. Evidence suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with chemotherapy. Previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and reducing inflammation (4). The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.
Detailed description
Tai-chi/Qi-gong is a complementary medicine technique that synergizes the mind-body connection. The technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The effect of Tai-chi/Qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. This trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. The patients will be allocated according to their preference to either the study or the control group. The Tai-chi/Qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. All patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).
Interventions
OTHERTai-chi/Qi-gong
Tai-chi/Qi-gong employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The treatments will take place once a week at the Dept. of the Gyneco-oncology and the patients will be instructed to practice tai-chi at home on a daily basis
Sponsors
Tel Aviv University
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with gynecological malignancies undergoing primary or secondary chemotherapy
Exclusion criteria
* Motor disability; * Less than 1 month since the last abdominal surgery; * Ascites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA | Week 0, Week 5, Week 10 | The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Visual Analog Scale for Pain | Week 0, Week 5, Week 10 | — |
| Change in the Lee Fatigue Scale (LFS) | Week 0, Week 5, Week 10 | The Lee Fatigue Scale (LFS). The questionnaire was compiled by Lee (7) and translated into Hebrew by Dr. Dorit Pud (6). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Hemoglobin in blood | Week 0, Week 3, Week 6, Week 9 | Results of the routine blood exams will be documented |
| Change in the C-reactive protein in blood | Week 0, Week 3, Week 6, Week 9 | — |
| Change in the Body Weight | Week 0, Week 5, Week 10 | — |
| Change in the number of Emergency Room visits | Week 0, Week 5, Week 10 | Emergency Room visits for nausea, vomiting, or dehydration |
| Pattern of use of Complementary Medicine | Week 0, Week 5, Week 10 | List of Complementary modalities used including Medical Cannabis |
| Change in the White Blood Cell Count | Week 0, Week 3, Week 6, Week 9 | Results of the routine blood exams will be documented |
Countries
Israel
Outcome results
None listed