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

Primary Purpose

Prostatic Neoplasms, Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
DOCETAXEL(XRP6976) + MODAFINIL
Modafinil
Placebo of Modafinil
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

docetaxel chemotherapy + modafinil 100 mg capsules

docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
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

Full Information

First Posted
June 8, 2009
Last Updated
September 25, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00917748
Brief Title
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
docetaxel chemotherapy + modafinil 100 mg capsules
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
Intervention Type
Drug
Intervention Name(s)
DOCETAXEL(XRP6976) + MODAFINIL
Intervention Description
arm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily
Intervention Type
Drug
Intervention Name(s)
Modafinil
Intervention Description
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
Intervention Type
Drug
Intervention Name(s)
Placebo of Modafinil
Intervention Description
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
Primary Outcome Measure Information:
Title
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
Time Frame
From baseline to the end of study (week 12)
Secondary Outcome Measure Information:
Title
Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
Time Frame
From baseline to the end of study (week 12)
Title
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
Time Frame
At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Title
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
At baseline and from visit 6 (week 3) to end of study (week 12)
Title
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
Time Frame
At baseline and from visit 6 (week 3) to end of study (week 12)
Title
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
Time Frame
At baseline and last visit= end of study (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosanna DUFFY
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24337761
Citation
Hovey 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.
Results Reference
derived

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

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