Cervical CancerPhase 2NCT00905658
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
A Phase 2 study testing therapeutic nutritional supplementation and standard follow-up care in people with Cervical Cancer and Endometrial Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
- What is being tested?
- therapeutic nutritional supplementation and standard follow-up care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
Isabelle Rodrigues-Lebrun, 33-32-029-5959
About this study
Official title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
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.
Read the 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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer
- Being tested
- therapeutic nutritional supplementation, standard follow-up care
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Sarcoma, Vaginal Neoplasms, Vulvar Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic nutritional supplementationDietary supplement
Patients receive systematic nutritional supplementation
standard follow-up careProcedure or surgery
Patients undergo standard monitoring
| Study group | Role | What they receive |
|---|---|---|
| Arm I | No intervention | Patients are monitored via standard follow-up assessments every 3 weeks. Receives: Procedure: standard follow-up care |
| Arm II | Experimental | Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks. Receives: Dietary Supplement: therapeutic nutritional supplementation; Procedure: 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. Receives: Dietary Supplement: therapeutic nutritional supplementation; Procedure: standard follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QLQ-C30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Investigators
- Isabelle Rodrigues-Lebrun, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905658
- Sponsor's protocol ID
- CDR0000633553
- Other IDs
- COL-NUTRYS, COL-2007-06, COL-IDRCB-2007-A00454-49, INCA-RECF0634
- Status last verified
- Jul 2009
- First submitted
- 19 May 2009
- Last updated
- 29 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
- ClinicalTrials.gov ID
- NCT00905658
- Acronym / sponsor ID
- CDR0000633553
- Conditions
- Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | No intervention | Procedure: standard follow-up carePatients are monitored via standard follow-up assessments every 3 weeks. |
| Arm II | Experimental | Dietary Supplement: therapeutic nutritional supplementation, Procedure: standard follow-up carePatients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks. |
| Arm III | Experimental | Dietary Supplement: therapeutic nutritional supplementation, Procedure: standard follow-up carePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic nutritional supplementationPatients receive systematic nutritional supplementation | Dietary supplement | Arm II, Arm III |
| standard follow-up carePatients undergo standard monitoring | Procedure or surgery | Arm I, Arm II, Arm III |
Primary outcome
Quality of life (QLQ-C30)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Rodrigues-Lebrun principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic nutritional supplementation and standard follow-up care in people with Cervical Cancer and Endometrial Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QLQ-C30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2009.