Lung CancerPhase 2NCT01881516
Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）
A Phase 2 study testing acupuncture in people with Lung Cancer and Cancer Related Fatigue, run by Fudan University.
Trial summary
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 ？ Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer, Cancer Related Fatigue
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）
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
- Lung Cancer, Cancer Related Fatigue
- Being tested
- acupuncture, sham acupuncture
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called Streitberger needles
once per week for 6 weeks，30 mins for each treatment and for seven main acupoints
sham acupunctureDevice
Also called Park Sham Device
the same acupoints and time as in acupuncture arm, but use a Park Sham Device
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks Receives: Device: acupuncture |
| sham acupuncture | Sham comparator | Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks. Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory, BFI
Measured: 12 months
Secondary outcomes (3)
MDASI-C
Measured: 12 months
number of adverse events of acupuncture
Measured: 24 months
FACT-L
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xie jing, Fudan University
- Investigators
- jing xie, MD, Principal investigator, Fudan Universityzhen chen, MD, Study director, Fudan Universityqiang zhi meng, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881516
- Sponsor's protocol ID
- CIM2013-F
- Status last verified
- Jun 2013
- First submitted
- 13 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）
- ClinicalTrials.gov ID
- NCT01881516
- Acronym / sponsor ID
- CIM2013-F
- Conditions
- Lung Cancer, Cancer Related Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ？
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Device: acupunctureParticipants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks |
| sham acupuncture | Sham comparator | Device: sham acupunctureParticipants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- Participants in other clinical research;
- Can not be pathologically or cytologically diagnosed as NSCLC;
- ECOG 3~4;
- Pregnant woman;
- >65 or <18 years old;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Streitberger needlesonce per week for 6 weeks，30 mins for each treatment and for seven main acupoints | Device | Acupuncture |
| sham acupunctureAlso: Park Sham Devicethe same acupoints and time as in acupuncture arm, but use a Park Sham Device | Device | sham acupuncture |
Primary outcome
Brief Fatigue Inventory, BFI
Time frame: 12 months
3 secondary outcomes
MDASI-C
Time frame: 12 months
number of adverse events of acupuncture
Time frame: 24 months
FACT-L
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jing xie, MD principal investigator
Fudan University
zhen chen, MD study director
Fudan University
qiang zhi meng, MD study chair
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture in people with Lung Cancer and Cancer Related Fatigue, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jing xie, MD (+86 021 64175590 ext. 3625, isable624@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory, BFI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.