CancerPhase 3NCT00200096
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial
A Phase 3 study testing Acupuncture and questionnaires in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical activity. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cancer
- What is being tested?
- Acupuncture and questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Feb 2011
- Phase
- Phase 3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 18 - 64 diagnosed with a malignancy (solid tumor or hematologic malignancy). We are excluding children primarily because fatigue in children is assessed differently from adults (56). Moreover, as children constitute only about 5% of the cancer population and as post-chemotherapy fatigue appears to be relatively rare in children (57), we would expect little if any accrual from the pediatric population. Patients aged 65 and over are excluded for likely non-response, as described under preliminary data.
- Patients must have received chemotherapy
- Patients must complain of fatigue following chemotherapy but not prior to chemotherapy
- At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. Acute chemotherapy related fatigue typically lasts two to three weeks at most (58). Patients with fatigue at 60 days can therefore be considered to be chronic cases.
- Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above. A score of four on the BFI is considered the threshold between "mild" and "moderate" symptoms (18).
Who cannot join
- Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks. Anemia is excluded as a major treatable cause of fatigue.
- Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. Patients with low platelets or neutrophils are at the risk of bleeding or infection, respectively.
- Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. Patients excluded for depression will be referred for appropriate psychiatric evaluation. Depression is excluded as a treatable cause of fatigue.
- Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
- Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
- Acupuncture in the previous six weeks.
- Change in use of any of the following drugs in the prior three weeks: opiates, anti-depressants (other than selective serotonin reuptake inhibitors [SSRIs]) / anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan-Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical activity. This study will involve about 88 patients.
Read the detailed description
Primary objective:
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Secondary objectives:
- To examine the long-term effects of acupuncture treatment on fatigue
- To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
- To examine the effect of acupuncture on levels of physical activity and quality of life.
- Conditions
- Cancer
- Being tested
- Acupuncture and questionnaires, placebo acupuncture
- Keywords
- Cancer, Fatigue
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and questionnairesProcedure or surgery
Acupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why.
On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated "posttreatment" values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation.
placebo acupunctureProcedure or surgery
During the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries.
Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Acupuncture and questionnaires Receives: Procedure: Acupuncture and questionnaires |
| 2 | Sham comparator | placebo acupuncture and questionnaires Receives: Procedure: placebo acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Measured: six weeks
Secondary outcomes (3)
To examine the long-term effects of acupuncture treatment on fatigue
Measured: six months
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
Measured: six months
To examine the effect of acupuncture on levels of physical activity and quality of life.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Gary Deng, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200096
- Sponsor's protocol ID
- 04-081
- Status last verified
- Feb 2011
- First submitted
- 9 Sep 2005
- Last updated
- 15 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial
- ClinicalTrials.gov ID
- NCT00200096
- Acronym / sponsor ID
- 04-081
- Conditions
- Cancer
- Keywords
- Cancer, Fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Sep 2005 (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.
In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical activity. This study will involve about 88 patients.
Detailed description
Primary objective:
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Secondary objectives:
- To examine the long-term effects of acupuncture treatment on fatigue
- To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
- To examine the effect of acupuncture on levels of physical activity and quality of life.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Acupuncture and questionnairesAcupuncture and questionnaires |
| 2 | Sham comparator | Procedure: placebo acupunctureplacebo acupuncture and questionnaires |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients age 18 - 64 diagnosed with a malignancy (solid tumor or hematologic malignancy). We are excluding children primarily because fatigue in children is assessed differently from adults (56). Moreover, as children constitute only about 5% of the cancer population and as post-chemotherapy fatigue appears to be relatively rare in children (57), we would expect little if any accrual from the pediatric population. Patients aged 65 and over are excluded for likely non-response, as described under preliminary data.
- Patients must have received chemotherapy
- Patients must complain of fatigue following chemotherapy but not prior to chemotherapy
- At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. Acute chemotherapy related fatigue typically lasts two to three weeks at most (58). Patients with fatigue at 60 days can therefore be considered to be chronic cases.
- Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above. A score of four on the BFI is considered the threshold between "mild" and "moderate" symptoms (18).
Key exclusion criteria (7 listed)
- Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks. Anemia is excluded as a major treatable cause of fatigue.
- Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. Patients with low platelets or neutrophils are at the risk of bleeding or infection, respectively.
- Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. Patients excluded for depression will be referred for appropriate psychiatric evaluation. Depression is excluded as a treatable cause of fatigue.
- Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
- Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
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 |
|---|---|---|
| Acupuncture and questionnairesAcupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why. On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated "posttreatment" values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation. | Procedure or surgery | 1 |
| placebo acupunctureDuring the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries. Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure. | Procedure or surgery | 2 |
Primary outcome
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Time frame: six weeks
3 secondary outcomes
To examine the long-term effects of acupuncture treatment on fatigue
Time frame: six months
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
Time frame: six months
To examine the effect of acupuncture on levels of physical activity and quality of life.
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Gary Deng, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture and questionnaires in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo (time frame: six weeks). 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 15 Feb 2011; AzTrials last refreshed its copy on 8 Nov 2026.