The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 01/31/2015 |
| Iliyowasilishwa Kwanza: | 02/14/2015 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 02/16/2015 |
| Iliyotumwa Kwanza: | 02/22/2015 |
| Sasisho la Mwisho Liliwasilishwa: | 02/16/2015 |
| Sasisho la Mwisho Lilichapishwa: | 02/22/2015 |
| Tarehe halisi ya kuanza kwa masomo: | 01/31/2015 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 11/30/2015 |
| Tarehe ya Kukamilisha Utafiti: | 11/30/2016 |
Hali au ugonjwa
Uingiliaji / matibabu
Other: Verum acupuncture and medicine
Other: Sham acupuncture and medicine
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Verum acupuncture and medicine Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other: Verum acupuncture and medicine Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
| Sham Comparator: Sham acupuncture and medicine Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other: Sham acupuncture and medicine Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: 1. Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer.They haven't receive any chemotherapy or radiotherapy treatment for three months prior to join this study. 2. Aged 18-75. 3. Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period. 4. ECOG score is between 0 and 2. 5. The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory. 6. The expected lifetime of the patient is longer than 6 months. 7. Patients willing to participate in the study and sign the consent form. Exclusion Criteria: 1. Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system. 2. Pregnant and lactating women. 3. Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertention, digestive tract obstruction, severe liver or Renal dysfunction, brain tumors, cerebrovascular disease, or other reasons. 4. Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders. 5. Patients have been definitely diagnosed with depression, anxiety disorders and psychosis 6. Patients with Sepsis or Bacteremia. 7. Patients have lymphedema in acupuncture stimulation area. 8. Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles can't participate in this study. |
Matokeo
Hatua za Matokeo ya Msingi
1. Change from Baseline in severity of nausea and vomiting at 21 days [It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings]
Hatua za Matokeo ya Sekondari
1. TCM symptoms scale [It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.]
2. ECOG score scale [It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.]
3. HADS [It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.]
