Clinical trial · Interventional
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
A Prospective, Randomised, Double-Blind, Placebo-Controlled Phase III Study of Modafinil to Improve Fatigue and Quality of Life in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer
- 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)
The primary objective is: * To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy The secondary objectives are: * To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy * To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy * To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy. * To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DOCETAXEL(XRP6976) + MODAFINIL | Drug | — | UNRESOLVED |
| Modafinil | Drug | — | UNRESOLVED |
| Placebo of Modafinil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- docetaxel chemotherapy + modafinil 100 mg capsules
- interventionNames
- Drug: DOCETAXEL(XRP6976) + MODAFINIL
- Drug: Modafinil
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
- interventionNames
- Drug: DOCETAXEL(XRP6976) + MODAFINIL
- Drug: Placebo of Modafinil
Primary outcomes (1)
- measure
- Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2 * Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy * Fatigue \> or = to 4 on the MD Anderson Symptom Inventory fatigue assessment scale during the previous docetaxel chemotherapy cycle * SPHERE somatic (SOMA) subscale score \> or = to 3 * Worsening of fatigue after commencement of docetaxel chemotherapy * Haemoglobin (Hb)\> or = to 10 g/dL within two weeks before randomisation Exclusion criteria: * Unable to complete the MD Anderson Symptom Inventory fatigue assessment scale or Functional Assessment of Chronic Illness Therapy-Fatigue Quality of Life survey * Require docetaxel chemotherapy dose reduction to less than 50 mg/m2 * History of chronic fatigue condition * Uncontrolled hypertension (blood pressure \> or = to 150/90 mm Hg * Known hypersensitivity / intolerance to modafinil or any of the excipients * Pregnant women * Psychological, familial, sociological, or geographical conditions that do not permit treatment or medical follow-up and / or prohibit compliance with the study protocol * Any serious concomitant illness that, in the opinion of the Investigator, would preclude a patient from participating in the study * Non-English speaking The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDHovey E, de Souza P, Marx G, Parente P, Rapke T, Hill A, Bonaventura A, Michele A, Craft P, Abdi E, Lloyd A; MOTIF investigators. Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Support Care Cancer. 2014 May;22(5):1233-42. doi: 10.1007/s00520-013-2076-0. Epub 2013 Dec 17. PMID 24337761