Clinical trial · Interventional
Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue(CRF)
Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue(CRF)
NCT01881516CI-TRIAL-00010823unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
we plan to conduct this trial to find out: * If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy? * How about the extent it relieves?the safety and applicability ? * What's the possible influential factor and mechanism ?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Related Fatigue | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture | Device | — | UNRESOLVED |
| sham acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acupuncture
- description
- Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks
- interventionNames
- Device: acupuncture
- type
- SHAM_COMPARATOR
- label
- sham acupuncture
- description
- Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.
- interventionNames
- Device: sham acupuncture
Primary outcomes (1)
- measure
- Brief Fatigue Inventory, BFI
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment; * Participants who meet the diagnosis criteria of CRF(ICD-10 criteria); * The first time to receive acupuncture treatment; * The age is between 18 and 65 years old; * Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above; * ECOG performance status 0, 1 or 2. * Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine \< 2.0 mg/dL, Bilirubin \< 1.5 mg/dL, ALT \< 3 x normal, albumin \>30g/L. * Have not taken any hypnotic, melatonin, or antidepressants within 30 days; * Willing to finish the whole observation period; * With written consent form signed by themselves. Exclusion Criteria: * Participants in other clinical research; * Can not be pathologically or cytologically diagnosed as NSCLC; * ECOG 3\~4; * Pregnant woman; * \>65 or \<18 years old; * Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue; * Patients who have received acupuncture ever before; * Received surgery, immunotherapy or target therapy within one month before the recruition; * Taking warfarin or heparin, a bleeding tendency exists; * Infection, ulceration or hyperalgesia at or near the local acupoints' skin,or with active infections; * There are cerebral vascular accident history or spinal cord injury history; * Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.; * Patients with a life expectancy \< 3 months; * Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
References
Publications (0)
Data not yet available
No reference posted for this study.