Clinical trial · Interventional
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial
NCT00658034CI-TRIAL-00005687unknownPhase 3ClinicalTrials.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)
This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| Placebo Acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Acupuncture
- interventionNames
- Procedure: Acupuncture
- type
- SHAM_COMPARATOR
- label
- 2
- description
- Placebo Acupuncture
- interventionNames
- Procedure: Placebo Acupuncture
Primary outcomes (1)
- measure
- To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
- timeFrame
- six weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy). * Patients must have received chemotherapy. * Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy. * At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. * Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above. Exclusion Criteria: * 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. * Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. * Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. * 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, antidepressants (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.
References
Publications (0)
Data not yet available
No reference posted for this study.