Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

Phase 3

Completed

• Conditions: Prostatic Neoplasms; Breast Cancer
• Interventions: Drug: DOCETAXEL(XRP6976) + MODAFINIL; Drug: Modafinil; Drug: Placebo of Modafinil

• Registration Number: NCT00917748
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	DOCETAXEL(XRP6976) + MODAFINIL	docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
1	DOCETAXEL(XRP6976) + MODAFINIL	docetaxel chemotherapy + modafinil 100 mg capsules
1	Modafinil	docetaxel chemotherapy + modafinil 100 mg capsules
2	Placebo of Modafinil	docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)

Primary Outcome Measures

Name	Time	Method
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	From baseline to the end of study (week 12)

Secondary Outcome Measures

Name	Time	Method
Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey	From baseline to the end of study (week 12)
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire	At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire	At baseline and from visit 6 (week 3) to end of study (week 12)
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)	At baseline and from visit 6 (week 3) to end of study (week 12)
Depression assessed using seven depression-related questions from the self-administered Hospital Anxiety and Depression (HAD) assessment subscale. Patient with depression will be defined as having the HAD-D> or = 8	At baseline and last visit= end of study (week 12)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇦🇺 Macquarie Park, Australia