Targeted Disruption to Cancer Metabolism and Growth Through Dietary Macronutrient Modification

NCT03171506 | Completed

• 1 other identifier: 317972
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this investigation is to examine the effects of 12 weeks of usual care plus a ketogenic diet (KD) or usual care plus dietary recommendations endorsed by the Academy of Nutrition and Dietetics (AND) in women with ovarian and endometrial cancer. Participants undergo testing at baseline and at 12 weeks; the testing consists of blood draws, questionnaires, and measures of body composition. The baseline visit also includes a meeting with a registered dietitian to discuss the guidelines of the assigned diet. It is hypothesized that the KD group will have improved cancer outcome measures, beneficial body composition changes, reduced fasting concentrations of glucose and insulin, and higher ratings of patient satisfaction with the diet relative to the AND group.

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

ketogenic diet; carbohydrate-restricted diet

Outcome Measures

Primary Outcomes (3)

• change in fasting glucose

  mg/dL

  12 weeks

• change in fasting insulin

  uU/mL

  12 weeks

• change in fasting beta-hydroxybutyrate

  mM

  12 weeks

Secondary Outcomes (12)

• CA-125

  baseline and 12 weeks

• IGF-1

  baseline and 12 weeks

• IGFBP-1

  baseline and 12 weeks

• markers of inflammation

  baseline and 12 weeks

• total body fat

  baseline and 12 weeks

Study Arms (2)

Usual care plus ketogenic diet

EXPERIMENTAL

Other: Ketogenic diet

Usual care plus AND diet

PLACEBO COMPARATOR

Other: AND diet

Interventions

Ketogenic diet OTHER

Participants in the usual care plus ketogenic diet group will receive usual care plus dietary counseling in accordance with a ketogenic diet such that \~5% energy comes from carbohydrate, 25% energy from protein, and 70% energy from fat for the duration of the 12 week study.

Usual care plus ketogenic diet

AND diet OTHER

Participants in the usual care plus AND diet group will receive usual care plus dietary counseling in accordance with the Academy of Nutrition and Dietetics guidelines in 2013 for the duration of the 12 week study.

Usual care plus AND diet

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: This trial is limited to female participants, as it is a study of ovarian and endometrial cancer patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• measurable disease or elevated CA-125
• classified as normal weight, overweight, or obese (BMI \> 18.5)
• English speaking \& reading
• can sign consent and are willing to be randomized and to adhere to the assigned protocol

You may not qualify if:

• pre-existing medical conditions that preclude enrollment: uncontrolled hypertension, myocardial infarction or cerebrovascular accident in the past six months, unstable angina within the last six months, congestive heart failure, serious infectious diseases, chronic hepatitis, cirrhosis, chronic malabsorption syndrome, chronic pancreatitis, chronic lung disease, major depressive or psychiatric disorder.
• current or medical condition that affects body weight such as uncontrolled hypo- or hyperthyroidism
• taking any of the following medications: anti-psychotic agents, monoamine oxidase inhibitors, antibiotics for HIV or tuberculosis, weight loss medications, or have taken weight loss medications in the last six months
• currently dieting

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Institute for Cancer Research: collaborator

Related Publications (4)

• Gower BA, Chandler-Laney PC, Ovalle F, Goree LL, Azziz R, Desmond RA, Granger WM, Goss AM, Bates GW. Favourable metabolic effects of a eucaloric lower-carbohydrate diet in women with PCOS. Clin Endocrinol (Oxf). 2013 Oct;79(4):550-7. doi: 10.1111/cen.12175. Epub 2013 May 20.

  PMID: 23444983 BACKGROUND

• Fine EJ, Segal-Isaacson CJ, Feinman RD, Herszkopf S, Romano MC, Tomuta N, Bontempo AF, Negassa A, Sparano JA. Targeting insulin inhibition as a metabolic therapy in advanced cancer: a pilot safety and feasibility dietary trial in 10 patients. Nutrition. 2012 Oct;28(10):1028-35. doi: 10.1016/j.nut.2012.05.001. Epub 2012 Jul 26.

  PMID: 22840388 BACKGROUND

• Cohen CW, Fontaine KR, Arend RC, Soleymani T, Gower BA. Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial. Nutrients. 2018 Aug 30;10(9):1187. doi: 10.3390/nu10091187.

  PMID: 30200193 DERIVED

• Cohen CW, Fontaine KR, Arend RC, Alvarez RD, Leath CA III, Huh WK, Bevis KS, Kim KH, Straughn JM Jr, Gower BA. A Ketogenic Diet Reduces Central Obesity and Serum Insulin in Women with Ovarian or Endometrial Cancer. J Nutr. 2018 Aug 1;148(8):1253-1260. doi: 10.1093/jn/nxy119.

  PMID: 30137481 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Interventions

Diet, Ketogenic; Diet

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Barbara A Gower, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized clinical trial with a parallel arm design to evaluate the effects of 12 weeks of usual care plus AND or usual care plus KD on women with ovarian and endometrial cancer.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 31, 2017
• Study Start: November 9, 2015
• Primary Completion: July 18, 2017
• Study Completion: July 18, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08