Endometrial CancerNCT02135562
Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors
A study testing Dietary Intervention, Informational Material and Dietary Education in people with Endometrial Cancer and Obesity, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer, Obesity
- What is being tested?
- Dietary Intervention, Informational Material and Dietary Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2014to 19 Apr 2017
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of endometrial cancer, successfully treated through surgery
- Body mass index (BMI) > 30 kg/m^2
- > 8 weeks removed from surgery to treat endometrial cancer
Who cannot join
- No previous diagnosis of endometrial cancer
- BMI < 30 kg/m^2
- Any history of cardiovascular, kidney, or liver disease
- Using medication to treat diabetes
- History of cardiac arrhythmias
- Inability to comply with follow up regimen
- Inability to read or speak English
- Abstention from meat and other animal products
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer survivors (ECS).
II. To assess whether the approach is feasible, whether participants will remain in the study for the duration of the intervention while adhering to the various components of the protocol. To assess feasibility, examine the following variables: drop-out rates; rates of adherence to diet and supplemental protocol; and rates of common side-effects.
III. Assess whether the PSMF improves biomarkers of disease risk in this population. To assess whether this objective has been met, assess the following variables: blood lipids (total cholesterol, low density lipid [LDL] cholesterol, high density lipid [HDL] cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein, interleukin-6, tumor necrosis factor [TNF]-alpha, and leptin).
IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss.
OUTLINE:
PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. The protein recommendation will be communicated to participants in terms of grams per day. Participants are encouraged to adhere as closely as possible to the protein recommendation. Based on the protein recommendation, participants are advised to consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that each ounce of these products contains seven grams of protein. Participants are provided with a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings of non-starchy vegetables per day. Participants remain on the PSMF until they have successfully reduced their initial body weight by 15% or up to 6 months. Participants are also provided with supplements to consume daily.
WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight, participants are instructed by a RD to consume a weight maintenance diet or they may remain on the PSMF. The weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy vegetables is unlimited. Participants receive handouts that list common foods and the number of carbohydrates in each serving and educated on nutrition label reading for carbohydrates, with emphasis on serving size and total number of carbohydrates per serving.
After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4, 5, and 6 months.
- Conditions
- Endometrial Cancer, Obesity
- Being tested
- Dietary Intervention, Informational Material, Dietary Education, Weight Maintenance, Average score of Obesity and Weight-Loss Quality of Life Questionnaire
- Keywords
- endometrial cancer, survivor, obesity, diet, high protein, protein-sparing modified fast intervention, PSMF
- Medical subject headings
- Endometrial Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary
Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.
Informational MaterialOther
Receive carbohydrate reintroduction handout
Dietary EducationOther
Also called intervention, educational
Receive education on nutrition label reading for carbohydrates
Weight MaintenanceDietary supplement
weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited
Average score of Obesity and Weight-Loss Quality of Life QuestionnaireOther
Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (PSMF) | Experimental | Participants will take part in a Protein-Sparing Modified Fast (PSMF) Intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks or until they have loss 15% of their body weight. This intervention will be followed by weight maintenance in which participants reintroduce non-starchy vegetables to their diet. At this time participants will also receive informational material and dietary education which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight-Loss Quality of Life Questionnaire to survey the impact of the intervention Receives: Dietary Supplement: Dietary Intervention; Other: Informational Material; Other: Dietary Education; Dietary Supplement: Weight Maintenance; Other: Average score of Obesity and Weight-Loss Quality of Life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weight loss assessed with the digital scale
Mean weight loss will be presented as mean total weight loss in kilograms from baseline
Measured: Baseline up to 6 months
Mean Weight loss assessed with the digital scale
Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.
Measured: Baseline up to 12 months
Secondary outcomes (13)
Changes in levels of total cholesterol
Average differences in total cholesterol between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Baseline up to 6 months
Changes in levels of markers of inflammation (C-reactive protein)
Average differences in C-reactive protein between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Up to 6 months
Changes in levels of glucose
Differences in glucose levels between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Up to 6 months
Number of drop-out participants
Presented as the difference in the number of participants who completed the study from the number of participants enrolled at baseline. This is reported as one of the markers of feasibility.
Measured: Up to 6 months
Average percentage of positive urinary ketone tests as a marker of dietary adherence
Assessed using the presence of urinary ketones beginning on day four of the intervention. Adherence rates will be presented as the percentage of positive urinary ketone tests for the duration of the intervention.
Measured: Up to 6 months
Number of Participant with reported side effects
Adverse events will be recorded by participants on a daily basis. Number of participants with related adverse events will be reported as one of the measures of feasibility
Measured: Up to 6 months
Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire
The difference between mean quality of life scores at the two time points will be assessed using a one-sided anova test with statistical significance set at p < 0.05.
Measured: Baseline up to 6 months
Changes in levels of markers of inflammation (interleukin 6)
Average differences in interleukin 6 between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Up to 6 months
Changes in levels of markers of inflammation (tumor necrosis factor - alpha)
Average differences in tumor necrosis factor - alpha between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Up to 6 months
Changes in levels of markers of inflammation (leptin)
Average differences of leptin between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Up to 6 months
Changes in levels of LDL-cholesterol
Average differences between time points for LDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Baseline up to 6 months
Changes in levels of HDL-cholesterol
Average differences between time points for HDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Baseline up to 6 months
Changes in levels of triglycerides
Average differences between time points for triglycerides will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start8 Aug 2014
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Resnick, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135562
- Sponsor's protocol ID
- CASE1814
- Other IDs
- NCI-2014-00832, CASE1814, CASE 1814, P30CA043703
- Status last verified
- Sep 2017
- First submitted
- 8 May 2014
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT02135562
- Acronym / sponsor ID
- CASE1814
- Conditions
- Endometrial Cancer, Obesity
- Keywords
- endometrial cancer, survivor, obesity, diet, high protein, protein-sparing modified fast intervention, PSMF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 12 May 2014 (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.
This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.
Detailed description
PRIMARY OBJECTIVES:
- Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer survivors (ECS).
II. To assess whether the approach is feasible, whether participants will remain in the study for the duration of the intervention while adhering to the various components of the protocol. To assess feasibility, examine the following variables: drop-out rates; rates of adherence to diet and supplemental protocol; and rates of common side-effects.
III. Assess whether the PSMF improves biomarkers of disease risk in this population. To assess whether this objective has been met, assess the following variables: blood lipids (total cholesterol, low density lipid [LDL] cholesterol, high density lipid [HDL] cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein, interleukin-6, tumor necrosis factor [TNF]-alpha, and leptin).
IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss.
OUTLINE:
PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. The protein recommendation will be communicated to participants in terms of grams per day. Participants are encouraged to adhere as closely as possible to the protein recommendation. Based on the protein recommendation, participants are advised to consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that each ounce of these products contains seven grams of protein. Participants are provided with a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings of non-starchy vegetables per day. Participants remain on the PSMF until they have successfully reduced their initial body weight by 15% or up to 6 months. Participants are also provided with supplements to consume daily.
WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight, participants are instructed by a RD to consume a weight maintenance diet or they may remain on the PSMF. The weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy vegetables is unlimited. Participants receive handouts that list common foods and the number of carbohydrates in each serving and educated on nutrition label reading for carbohydrates, with emphasis on serving size and total number of carbohydrates per serving.
After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4, 5, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (PSMF) | Experimental | Dietary Supplement: Dietary Intervention, Other: Informational Material, Other: Dietary Education, Dietary Supplement: Weight Maintenance, Other: Average score of Obesity and Weight-Loss Quality of Life QuestionnaireParticipants will take part in a Protein-Sparing Modified Fast (PSMF) Intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks or until they have loss 15% of their body weight. This intervention will be followed by weight maintenance in which participants reintroduce non-starchy vegetables to their diet. At this time participants will also receive informational material and dietary education which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight-Loss Quality of Life Questionnaire to survey the impact of the intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous diagnosis of endometrial cancer, successfully treated through surgery
- Body mass index (BMI) > 30 kg/m^2
- > 8 weeks removed from surgery to treat endometrial cancer
Key exclusion criteria (8 listed)
- No previous diagnosis of endometrial cancer
- BMI < 30 kg/m^2
- Any history of cardiovascular, kidney, or liver disease
- Using medication to treat diabetes
- History of cardiac arrhythmias
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 |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietaryFollow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. | Dietary supplement | Supportive Care (PSMF) |
| Informational MaterialReceive carbohydrate reintroduction handout | Other | Supportive Care (PSMF) |
| Dietary EducationAlso: intervention, educationalReceive education on nutrition label reading for carbohydrates | Other | Supportive Care (PSMF) |
| Weight Maintenanceweight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited | Dietary supplement | Supportive Care (PSMF) |
| Average score of Obesity and Weight-Loss Quality of Life QuestionnaireParticipants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life. | Other | Supportive Care (PSMF) |
Primary outcome
Mean Weight loss assessed with the digital scale
Time frame: Baseline up to 6 months
Mean weight loss will be presented as mean total weight loss in kilograms from baseline
Mean Weight loss assessed with the digital scale
Time frame: Baseline up to 12 months
Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.
13 secondary outcomes
Changes in levels of total cholesterol
Time frame: Baseline up to 6 months
Changes in levels of markers of inflammation (C-reactive protein)
Time frame: Up to 6 months
Changes in levels of glucose
Time frame: Up to 6 months
Number of drop-out participants
Time frame: Up to 6 months
Average percentage of positive urinary ketone tests as a marker of dietary adherence
Time frame: Up to 6 months
Number of Participant with reported side effects
Time frame: Up to 6 months
Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire
Time frame: Baseline up to 6 months
Changes in levels of markers of inflammation (interleukin 6)
Time frame: Up to 6 months
Changes in levels of markers of inflammation (tumor necrosis factor - alpha)
Time frame: Up to 6 months
Changes in levels of markers of inflammation (leptin)
Time frame: Up to 6 months
Changes in levels of LDL-cholesterol
Time frame: Baseline up to 6 months
Changes in levels of HDL-cholesterol
Time frame: Baseline up to 6 months
Changes in levels of triglycerides
Time frame: Baseline up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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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.
Kimberly Resnick principal investigator
Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention, Informational Material and Dietary Education in people with Endometrial Cancer and Obesity, run by Case Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weight loss assessed with the digital scale (time frame: Baseline up to 6 months). The study lists 2 primary outcomes in all. 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 20 Sep 2017.