Clinical trial · Interventional
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
NCT01091974CI-TRIAL-00025888completedPhase 2Results postedClinicalTrials.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 four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| armodafinil | Drug | — | UNRESOLVED |
| CBT-I | Behavioral | — | UNRESOLVED |
| Placebo Comparator | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1 - CBT-I + placebo
- description
- CBT-I and placebo
- interventionNames
- Drug: Placebo Comparator
- Behavioral: CBT-I
- type
- EXPERIMENTAL
- label
- 2 - CBT-I + Armodafinil
- description
- CBT-I + Armodafinil
- interventionNames
- Drug: armodafinil
- Behavioral: CBT-I
- type
- PLACEBO_COMPARATOR
- label
- 3 - Placebo only
- description
- Placebo only
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have a diagnosis of cancer. 2. Be able to understand written and spoken English 3. Be able to swallow medication 4. Have preferred sleep phase between 7:30 pm and 11:00 am 5. Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period 6. Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted 7. Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment 8. Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.) 9. Report insomnia on the SDS-CL at a frequency of at least 3 days a week Exclusion Criteria: 1. Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component. 2. Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years) 3. Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension 4. Be presently taking an anticoagulant or a corticosteroid 5. Have taken amphetamines (e.g., methylphenidate, pemoline \[Cylert®\] or similar psycho stimulants) within the past 30 days 6. Be currently pregnant or nursing 7. Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score \>=2 or an Alcohol Use Disorders Identification Test (AUDIT) score \>=13 8. Have surgery planned within the study period 9. Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.
References
Publications (3)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811
- DERIVEDPeoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors. J Clin Sleep Med. 2019 Jan 15;15(1):129-137. doi: 10.5664/jcsm.7586. PMID 30621831
- DERIVEDRoscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015 Jan 10;33(2):165-71. doi: 10.1200/JCO.2014.57.6769. Epub 2014 Dec 1. PMID 25452447