Anorexia, Cancer Cachexia
Conditions
Keywords
Cancer Anorexia Cachexia Syndrome, Acupuncture, Megestrol acetate, Poor Appetite, Anorexia, Randomized Controlled Trial
Brief summary
This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.
Detailed description
Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.
Interventions
OTHERAcupuncture
Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
OTHERSham Acupuncture
Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.
DRUGMegestrol Acetate
Megestrol Acetate 160mg tablet
DRUGPlacebo(Megestrol Acetate)
Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
Sponsors
Chengdu University of Traditional Chinese Medicine
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed gastrointestinal tand lung cancers; 2. Age ≥18 years; 3. Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening; 4. Had a history of weight loss ≥5% within 6 moths; 5. Maintained oral intake; 6. Signed the informed consent.
Exclusion criteria
1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation; 2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ; 3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism); 4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide) 5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture; 6. Lifetime expected less than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appetite Visual Analog Scale | Baseline, the days 8 and 15. | The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Council of Nutrition appetite questionnaire (CNAQ) | Baseline, the days 8 and 15. | Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months. |
| Caloric intake | Baseline, the days 8 and 15. | The caloric intake will be assessed by the dietician. |
| Functional Assessment of Anorexia/Cachexia Therapy | Baseline, the days 8 and 15. | Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns. |
| Nutritional status | Baseline, the days 8 and 15. | weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined |
Other
| Measure | Time frame | Description |
|---|---|---|
| Edmonton Symptom Assessment Scale | Baseline, the days 8 and 15. | Edmonton Symptom Assessment Scale is a nine-item patient-rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care. |
| The Questionnaire of Acupuncture-related Events(QAE) | Baseline and the days 7 | The side effects and their detail will be record during and after the acupuncture. |
Countries
China
Contacts
Primary ContactZihui Xu, PhD
Backup ContactYe Cui, MD
Outcome results
None listed