Clinical trial NCT00905658: Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Official title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Keywords: stage IVA cervical cancer
stage IVB cervical cancer
fallopian tube cancer
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
stage IV endometrial carcinoma
stage IV uterine sarcoma
stage IVA vaginal cancer
stage IVB vaginal cancer
stage IV vulvar cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: OBJECTIVES:

Primary

* Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.

Secondary

* Study the maintenance or improvement of intake and nutritional status.
* Study the quality of life during chemotherapy.
* Evaluate tolerance and compliance to treatment with nutritional supplements.
* Evaluate the feasibility of and the tolerance to chemotherapy.
* Measure the overall survival over 18 weeks.
* Analyze the cost-effectiveness of different strategies of nutritional care.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients are monitored via standard follow-up assessments every 3 weeks.
* Arm II: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
* Arm III: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life (QLQ-C30)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Isabelle Rodrigues-Lebrun
role: PRINCIPAL_INVESTIGATOR
References: