Nutritional Supplement Shakes for Ovarian Cancer

Not currently recruiting at 8 trial locations

Overseen By Vance Broach, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Neoadjuvant chemotherapy, Diabetes, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special nutrition shake can support individuals preparing for debulking surgery for ovarian, fallopian tube, or primary peritoneal cancer. Participants will consume three Ensure Surgery Immunonutrition Shake supplements daily for a week before surgery to assess improvements in surgical readiness. The trial seeks individuals scheduled for these surgeries who have at least eight days before the procedure to begin the shake regimen. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially improved surgical outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ensure Surgery Immunonutrition Shake supplements are safe?

Research shows that the Ensure Surgery Immunonutrition Shake supports the immune system and aids recovery after surgery. It contains high-quality protein, arginine (a nutrient), and fish oil, which assist in tissue repair and wound healing. Past studies have involved participants consuming two to three shakes daily for five to seven days before surgery, a protocol this study also plans to follow.

Doctors often recommend Ensure, the brand behind this shake. Products from trusted brands like Ensure are usually well-tolerated by most people. Although specific data on side effects for this shake is not available, its ingredients are common in nutritional supplements and are generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ensure Surgery Immunonutrition Shake supplements because they offer a unique approach to supporting patients undergoing debulking surgery for ovarian cancer. Unlike traditional treatments that focus primarily on surgical and chemotherapeutic interventions, this nutritional supplement is designed to enhance the patient's immune function and overall nutritional status before surgery. The shakes contain a blend of nutrients specifically formulated to potentially improve surgical outcomes and recovery times. By fortifying the body ahead of surgery, these supplements might give patients a better starting point for healing, something current standard care options do not address directly.

What evidence suggests that the Ensure Surgery Immunonutrition Shake supplements are effective for preoperative nutritional support?

Research has shown that drinking immunonutrition shakes, such as Ensure Surgery Immunonutrition Shake, before surgery can be beneficial. In previous studies, participants gained an average of 3.8 kg, indicating strong nutritional support. Using these shakes around the time of surgery has also been linked to fewer infections and shorter hospital stays. Additionally, patients who received nutritional care after surgery were less likely to return to the hospital within 30 days. In this trial, participants will drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days before their scheduled procedure. These findings suggest that Ensure Surgery Immunonutrition Shake could help improve recovery and outcomes for surgical patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Vance Broach, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Age ≥ 18

Scheduled to undergo primary surgical debulking of ovarian, fallopian tube and primary peritoneal cancer

Have a sufficient preoperative window during which the intervention can occur, with the last day of supplementation at least one and no more than two days prior to surgery; scheduling of the procedure should not be delayed due to participation in this investigation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Nutrition Intervention

Participants consume three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure

1 week

Follow-up

Participants are monitored for safety and effectiveness after the nutritional intervention and surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ensure Surgery Immunonutrition Shake supplements

How Is the Trial Designed?

Group I: Ensure Surgery Immunonutrition Shake supplements Experimental Treatment 2 Interventions

Participants will be provided with and instructed to drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1048891X25011004

Preoperative immunonutrition for patients who undergo ... Participants demonstrated a median weight gain of 3.8 kg over the study period, with high compliance, consuming an average of 2.2 Ensure Surgery ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03692507

Effects of Nutritional Preconditioning on the Patient's ... Patients in the third group (High protein) will drink 2- 8oz bottles of Ensure surgery daily (morning and night) for 5 days prior to surgery. Each bottle ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/390270

Perioperative Immunonutrition in Patients Undergoing ... Perioperative administration of a supplemented enteral formula significantly reduced postoperative infections and length of stay in patients undergoing surgery ...

4. researchgate.net researchgate.net/publication/326813315_How_Addressing_Nutrition_Pre-_and_Post-Op_Can_Have_a_Long-Lasting_Impact_on_Surgical_Patients

How Addressing Nutrition Pre- and Post-Op Can Have a ... The data showed that for the more than 300 surgical patients in the study who received nutrition care post-surgery, they had reduced 30-day hospital readmission ...

5. withpower.com withpower.com/trial/phase-intestinal-diseases-2-2024-0e18a

Pre-operative Nutrition for Inflammatory Bowel Disease Studies have shown that drinking immunonutrition shakes before surgery helps the bowel recover faster. This nutrition may also lower the risk of post-surgery ...

6. abbottnutrition.com abbottnutrition.com/our-products/ensure-surgery

Ensure® Surgery Immunonutrition shake. ENSURE SURGERY is specially designed to support immune health and recovery from surgery. For oral use. Use under medical supervision.

7. ensure.com ensure.com/nutrition-products/ensure-surgery

Ensure® Surgery Drink | Liquid Diet After ... The Ensure Surgery Immunonutrition Shake, from the #1 doctor-recommended brand* Ensure, contains high-quality protein, arginine, and fish oil to help your body ...

8. abbottstore.com abbottstore.com/adult-nutrition/ensure/ensure-surgery/ensure-surgery-immunonutritionshake/ensure-surgery-immunonutrition-shake-vanilla-8-fl-oz-bottle-case-of-24-65047.html?srsltid=AfmBOoqXpAJqVYG2YJRp0vIb5kNR2hRwZRoIqwLrGN1ltc4MhF5-hVHQ

Ensure Surgery Immunonutrition Shake / Vanilla / 8 fl oz ... Ensure Surgery immunonutrition shake contains 18 grams of high-quality protein to support tissue repair and wound healing. It also has EPA & DHA (omega-3 fatty ...

9. amazon.com amazon.com/Ensure-Perioperative-Pre-Surgery-Carbohydrate-Immunonutrition/dp/B07ZRG1BQJ

Ensure Surgery Perioperative 5-Day Bundle with 3 ... A high-protein nutrition shake with arginine + fish oil to support immune health and surgical recovery. Drink2-3 shakes per day for 5-7 days before surgery.

10. mms.mckesson.com mms.mckesson.com/product/1053428/Abbott-Nutrition-66436

Oral Supplement Ensure® Surgery Immunonutrition Ensure Surgery is specifically designed to support immune health and recovery from surgery · Contains 1.1 gram EPA & DHA (omega-3 fatty acids from fish oil) and ...