Stage I Colon CancerNCT02129218
Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
A study testing questionnaire administration, laboratory biomarker analysis and Standard Dietary Intervention in people with Stage I Colon Cancer and Stage II Colon Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This pilot clinical trial studies the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Colon Cancer, Stage II Colon Cancer, Stage III Colon Cancer
- What is being tested?
- questionnaire administration, laboratory biomarker analysis and Standard Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2015to 10 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
- Patients must regularly consume a diet with a glycemic load > 150 as estimated through the 3 day food recall
- Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
Who cannot join
- Current participation in an intervention targeting diet or exercise
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Metrohealth Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
This pilot clinical trial studies the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help decrease the chance of cancer coming back and improve the survival in patients with colon cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of following a low or medium glycemic load diet in patients with stage I-III (local-regional) colon cancer.
SECONDARY OBJECTIVES:
- To determine patient-reported acceptability of diet. II. To determine nutritionist resources utilized. III. To evaluate the effect of lowering dietary glycemic load on body mass index (BMI), lipid metabolism and pro-oncogenic intermediaries of cellular metabolism.
OUTLINE: Patients are sequentially enrolled in 1 of 4 possible cohorts as needed based on the feasibility of the prior cohort.
COHORT 1: Patients follow a low glycemic load diet with standard dietary intervention (contact with nutritionist in person every 2 weeks with phone contact on the alternating weeks) for 12 weeks.
COHORT 2: Patients follow a low glycemic load diet with intensified dietary intervention (contact with nutritionist in person every week) for 12 weeks.
COHORT 3: Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
COHORT 4: Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
- Conditions
- Stage I Colon Cancer, Stage II Colon Cancer, Stage III Colon Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer
- Being tested
- questionnaire administration, laboratory biomarker analysis, Standard Dietary Intervention, Intensified Dietary Intervention, Low glycemic load
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
laboratory biomarker analysisOther
Correlative studies
Standard Dietary InterventionBehavioural
Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
Intensified Dietary InterventionBehavioural
Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
Low glycemic loadBehavioural
Medium Glycemic LoadBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Low glycemic load with standard diet | Experimental | Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks. Receives: Other: questionnaire administration; Behavioral: Standard Dietary Intervention; Behavioral: Low glycemic load |
| Cohort 2: Low glycemic load with intensified diet | Experimental | Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks. Receives: Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: Intensified Dietary Intervention; Behavioral: Low glycemic load |
| Cohort 3: Medium glycemic load with standard diet | Active comparator | Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks. Receives: Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: Standard Dietary Intervention; Behavioral: Medium Glycemic Load |
| Cohort 4: Medium glycemic load with intensified diet | Active comparator | Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks. Receives: Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: Intensified Dietary Intervention; Behavioral: Medium Glycemic Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
This compliance rate will be determined through conducting a 24 hour telephone recall, every 2 weeks at random and calculating the glycemic load. For each dose cohort, the number and percentage of patients who are compliant will be summarized, with 90% confidence interval that accounts for the two-stage design.
Measured: Up to week 12
Secondary outcomes (2)
Food acceptability score
Results of the acceptability survey will be tabulated and described (the questions use a 7 point likert scale), separately for each cohort.
Measured: Up to 12 weeks
Hours of nutritionist time per week
The median number of hours will be calculated based on time spent with each patient, separately for each cohort.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start16 Feb 2015
- Primary completion14 Jun 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Colon 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- Michelle Treasure, MD, Study director, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129218
- Sponsor's protocol ID
- CASE7213
- Other IDs
- NCI-2014-00831, CASE7213, P30CA043703
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2014
- Last updated
- 20 Jul 2018
- 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 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
- ClinicalTrials.gov ID
- NCT02129218
- Acronym / sponsor ID
- CASE7213
- Conditions
- Stage I Colon Cancer, Stage II Colon Cancer, Stage III Colon Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 2 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 the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help decrease the chance of cancer coming back and improve the survival in patients with colon cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of following a low or medium glycemic load diet in patients with stage I-III (local-regional) colon cancer.
SECONDARY OBJECTIVES:
- To determine patient-reported acceptability of diet. II. To determine nutritionist resources utilized. III. To evaluate the effect of lowering dietary glycemic load on body mass index (BMI), lipid metabolism and pro-oncogenic intermediaries of cellular metabolism.
OUTLINE: Patients are sequentially enrolled in 1 of 4 possible cohorts as needed based on the feasibility of the prior cohort.
COHORT 1: Patients follow a low glycemic load diet with standard dietary intervention (contact with nutritionist in person every 2 weeks with phone contact on the alternating weeks) for 12 weeks.
COHORT 2: Patients follow a low glycemic load diet with intensified dietary intervention (contact with nutritionist in person every week) for 12 weeks.
COHORT 3: Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
COHORT 4: Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Low glycemic load with standard diet | Experimental | Other: questionnaire administration, Behavioral: Standard Dietary Intervention, Behavioral: Low glycemic loadPatients follow a low glycemic load diet with a standard dietary intervention for 12 weeks. |
| Cohort 2: Low glycemic load with intensified diet | Experimental | Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: Intensified Dietary Intervention, Behavioral: Low glycemic loadPatients follow a low glycemic load diet with intensified dietary intervention for 12 weeks. |
| Cohort 3: Medium glycemic load with standard diet | Active comparator | Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: Standard Dietary Intervention, Behavioral: Medium Glycemic LoadPatients follow a medium glycemic load diet with standard dietary intervention for 12 weeks. |
| Cohort 4: Medium glycemic load with intensified diet | Active comparator | Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: Intensified Dietary Intervention, Behavioral: Medium Glycemic LoadPatients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
- Patients must regularly consume a diet with a glycemic load > 150 as estimated through the 3 day food recall
- Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
Key exclusion criteria (1 listed)
- Current participation in an intervention targeting diet or exercise
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 |
|---|---|---|
| questionnaire administrationAncillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire. | Other | Cohort 1: Low glycemic load with standard diet, Cohort 2: Low glycemic load with intensified diet, Cohort 3: Medium glycemic load with standard diet, Cohort 4: Medium glycemic load with intensified diet |
| laboratory biomarker analysisCorrelative studies | Other | Cohort 2: Low glycemic load with intensified diet, Cohort 3: Medium glycemic load with standard diet, Cohort 4: Medium glycemic load with intensified diet |
| Standard Dietary InterventionParticipants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc). | Behavioural | Cohort 1: Low glycemic load with standard diet, Cohort 3: Medium glycemic load with standard diet |
| Intensified Dietary InterventionPatients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress. | Behavioural | Cohort 2: Low glycemic load with intensified diet, Cohort 4: Medium glycemic load with intensified diet |
| Low glycemic load | Behavioural | Cohort 1: Low glycemic load with standard diet, Cohort 2: Low glycemic load with intensified diet |
| Medium Glycemic Load | Behavioural | Cohort 3: Medium glycemic load with standard diet, Cohort 4: Medium glycemic load with intensified diet |
Primary outcome
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
Time frame: Up to week 12
This compliance rate will be determined through conducting a 24 hour telephone recall, every 2 weeks at random and calculating the glycemic load. For each dose cohort, the number and percentage of patients who are compliant will be summarized, with 90% confidence interval that accounts for the two-stage design.
2 secondary outcomes
Food acceptability score
Time frame: Up to 12 weeks
Hours of nutritionist time per week
Time frame: Up to 12 weeks
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 Jul 2018.
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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.
Michelle Treasure, MD study director
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 questionnaire administration, laboratory biomarker analysis and Standard Dietary Intervention in people with Stage I Colon Cancer and Stage II Colon Cancer, 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 1 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 Jul 2018. 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?
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12 (time frame: Up to week 12). 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 Jul 2018.