NCT00905658

Brief Summary

RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment. PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

1.4 years

First QC Date

May 19, 2009

Last Update Submit

July 28, 2009

Conditions

Cervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerSarcomaVaginal CancerVulvar Cancer

Keywords

stage IVA cervical cancerstage IVB cervical cancerfallopian tube cancerstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerstage IV endometrial carcinomastage IV uterine sarcomastage IVA vaginal cancerstage IVB vaginal cancerstage IV vulvar cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life (QLQ-C30)

Study Arms (3)

Arm I

NO INTERVENTION

Patients are monitored via standard follow-up assessments every 3 weeks.

Procedure: standard follow-up care

Arm II

EXPERIMENTAL

Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.

Dietary Supplement: therapeutic nutritional supplementationProcedure: standard follow-up care

Arm III

EXPERIMENTAL

Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.

Dietary Supplement: therapeutic nutritional supplementationProcedure: standard follow-up care

Interventions

therapeutic nutritional supplementationDIETARY_SUPPLEMENT

Patients receive systematic nutritional supplementation

Arm IIArm III
standard follow-up carePROCEDURE

Patients undergo standard monitoring

Arm IArm IIArm III

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed gynecological cancer * Currently receiving first-line chemotherapy for metastatic disease PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 or Karnofsky PS 70-100% * Not pregnant or nursing * Intake \< 75% of theoretical need * Weight loss ≥ 5% within the past 6 months * No patients with dementia or altered mental status * No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsSarcomaVaginal NeoplasmsVulvar NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeVaginal DiseasesVulvar DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • Isabelle Rodrigues-Lebrun

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

FR(1)