Nutrition and Exercise Intervention for Cancer in Older Adults

(NOSH Trial)

Overseen By Kathryn N. Starr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Sorafenib

Disqualifiers: Stage I or IV cancer, others

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

Compensation: Varies

Number of Visits: Unknown

188 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on the chemotherapy drug Sorafenib, you cannot participate in the trial.

What data supports the effectiveness of the treatment Structured perioperative nutrition and exercise for cancer in older adults?

Research shows that perioperative nutrition, including oral nutritional supplements, can improve recovery after surgery, especially in patients with poor nutrition. Enhanced Recovery After Surgery (ERAS) protocols, which include nutritional support, have been shown to improve surgical outcomes in various conditions, suggesting potential benefits for cancer patients as well. ^{1 2 3 4 5}

Is the nutrition and exercise intervention generally safe for humans?

Research suggests that nutrition and exercise interventions before surgery are generally safe and can improve recovery, reduce complications, and shorten hospital stays. These interventions are recommended for patients at nutritional risk, and guidelines support their use to ensure adequate nutrient intake. ^{4 6 7 8 9}

How is the treatment 'Structured perioperative nutrition and exercise' different from other treatments for cancer in older adults?

This treatment is unique because it combines nutrition and exercise interventions specifically before and after surgery to improve outcomes in older cancer patients, addressing the often neglected issue of malnutrition and physical decline during cancer treatment. ^{3 8 10 11 12}

What is the purpose of this trial?

In this pragmatic clinical trial, the investigators will study older Veterans approaching surgery for gastrointestinal or genitourinary cancer who are at high risk for a marked decline in their physical function. The investigators will test a multi-targeted nutrition regimen high in protein and other key nutrients and including resistance exercise, administered 8 weeks prior to surgery and for 24 weeks after discharge from surgery, with the goal of protecting physical function and improving physiologic, metabolic, and patient-centered outcomes. The findings of this study will promote a better intervention to compensate for the high nutritional demands of cancer and its treatment and lead to stronger, more rapid physical recoveries and better quality of life for older adults with moderate to advanced cancer-a group that has rarely been included in long-term nutrition studies. In addition to providing direct benefits to Veterans, the study may also benefit the VA by decreasing demands on the health care system via hastening the recovery of physical function.

Research Team

Kathryn N. Starr, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

This trial is for older Veterans over 60 with Stage II or III cancer of the bladder, colon, kidney, liver, pancreas, stomach or rectum who are English-speaking and can record their diet (or have someone who can). They must be scheduled for surgery in 6 weeks and have normal kidney function. Those with early-stage I or advanced stage IV cancer, severe diabetes, weight over 450 lbs., certain neurological conditions or severe heart failure cannot join.

Inclusion Criteria

My surgery is planned within 6 weeks from giving consent.

English speaking

I am willing and able to follow any treatment plan I am assigned to.

Exclusion Criteria

I have lost significant weight recently and my doctors think I have less than 9 months to live.

My cancer is diagnosed as either Stage I or Stage IV.

My kidney function is reduced with a GFR under 45 mL/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Nutrition and Exercise

Participants receive a multi-targeted nutrition regimen high in protein and other key nutrients, including resistance exercise, administered 8 weeks prior to surgery.

8 weeks

Post-Surgery Nutrition and Exercise

Participants continue the nutrition and exercise regimen for 24 weeks after discharge from surgery to protect physical function and improve outcomes.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, within 24 hours before surgery, 30-days post-op, 12-weeks following post-op visit, and 24 weeks following post-op visit.

24 weeks

Treatment Details

Interventions

• Structured perioperative nutrition and exercise

Trial Overview The study tests a nutrition and exercise program before and after surgery for gastrointestinal/genitourinary cancer. Participants will follow a high-protein diet with key nutrients plus resistance exercise starting from 8 weeks pre-surgery to 24 weeks post-discharge. The goal is to preserve physical function and improve recovery outcomes.

Participant Groups

Group I: NOSH Experimental Treatment 1 Intervention

Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm

Group II: Typical Regimen Active Control 1 Intervention

Typical Regimen Arm

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Implementing an early recovery after surgery (ERAS) protocol that emphasizes early oral food intake is the preferred approach for managing patients undergoing major surgery, suggesting a shift away from traditional artificial nutritional support.

Despite the prevalence of obesity, many patients may still face malnutrition or sarcopenia, highlighting the importance of identifying those at metabolic risk who may benefit from targeted nutritional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perioperative nutritional supplementation-what is really evidence based?] Weimann, A.[2021]

Preoperative nutritional support is beneficial only for patients with high-grade malnutrition, as it can significantly reduce postoperative complications and mortality in this group.

Postoperative nutritional support is only effective for patients who cannot eat adequately within one week after surgery, but it carries risks, including a 20% incidence of cardiopulmonary complications with total parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perioperative nutritional therapy and its relevance for postoperative outcome]. Müller, JM., Thul, P., Ablassmaier, B.[2019]

This randomized controlled trial aims to evaluate the effectiveness of oral nutrition supplements (ONS) on nutritional and clinical outcomes in non-severely malnourished patients undergoing elective surgery for breast and colorectal cancer, involving multiple intervention groups over a 90-day period.

The study will assess various primary and secondary endpoints, including changes in weight, BMI, serum albumin levels, and muscle strength, to determine if perioperative ONS can improve recovery and reduce complications in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. Wong, TX., Chen, ST., Ong, SH., et al.[2021]

Enhanced recovery after surgery (ERAS) emphasizes the importance of enteral nutrition (EN) through oral nutritional supplements (ONS) or tube feeding (TF) to ensure adequate nutrient intake, especially for patients unable to eat for more than 7 days or maintain 60% of their nutritional needs for over 10 days.

Early initiation of nutritional support is crucial; it is recommended to start EN therapy as soon as a patient shows signs of nutritional risk, rather than waiting for severe undernutrition to develop, to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Weimann, A., Braga, M., Harsanyi, L., et al.[2022]

A study involving 61 patients with Inflammatory Bowel Disease (IBD) showed that nutritional prehabilitation before elective surgery significantly improved body composition, including weight and lean body mass, particularly in patients at high nutritional risk.

Early resumption of oral feeding after surgery was associated with shorter hospital stays and quicker recovery of bowel function, indicating that this approach is both feasible and beneficial for IBD patients in an Enhanced Recovery After Surgery (ERAS) setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-lasting nutritional prehabilitation on postoperative outcome in elective surgery for IBD. Fiorindi, C., Cuffaro, F., Piemonte, G., et al.[2021]

Multimodal prehabilitation, which includes both nutrition and exercise, can improve functional walking capacity and pulmonary function in lung cancer patients before surgery, although it does not seem to affect postoperative outcomes.

A nutrition-only intervention showed a significant reduction in postoperative complications, suggesting that optimizing preoperative nutrition may provide important benefits that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Ferreira, V., Lawson, C., Ekmekjian, T., et al.[2021]

Patients undergoing complex surgeries, like cancer resections, often face significant nutrition risks before and after their operations, which can complicate recovery.

Novel strategies for assessing nutrition risk and managing nutrition before and after surgery are essential to improve outcomes for these high-risk patients, as highlighted in discussions at the American Society for Parenteral and Enteral Nutrition 2022 Preconference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition for the high-risk surgical patient, when they need it most: Question and answer session. Morrison, C., Prado, CM., Wischmeyer, P., et al.[2023]

Exercise training before elective major surgery is feasible, safe, and shows potential benefits in reducing complications and hospital stay, although more extensive studies are needed to confirm these effects.

Nutritional interventions are less studied and often combined with exercise, indicating a need for further research to evaluate their effectiveness and understand how they work together in prehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation and Nutritional Support to Improve Perioperative Outcomes. West, MA., Wischmeyer, PE., Grocott, MPW.[2023]

Malnutrition significantly increases the risk of poor postoperative outcomes, with about 40% of patients undergoing major surgery identified as being at nutritional risk based on current diagnostic criteria.

Using the Nutritional Risk Score can effectively identify patients who need nutritional support, and preoperative oral supplementation for at least five days can lead to fewer complications and shorter hospital stays, but adherence to nutritional guidelines by surgeons is still lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative nutrition in abdominal surgery: recommendations and reality. Cerantola, Y., Grass, F., Cristaudi, A., et al.[2021]

Malnutrition is a common issue in cancer patients, particularly those undergoing surgery, and is linked to worse outcomes such as longer hospital stays, higher complication rates, and increased mortality.

Despite existing guidelines for nutritional care, there is a significant gap in the implementation of nutritional assessments and support in surgical oncology, highlighting the need for better collaboration between surgeons and nutrition specialists to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative nutrition and enhanced recovery after surgery in gastrointestinal cancer patients. A position paper by the ESSO task force in collaboration with the ERAS society (ERAS coalition). Sandrucci, S., Beets, G., Braga, M., et al.[2018]

In a study of 102 patients, those who received preoperative nutritional supplementation for 14 days experienced significantly fewer serious postoperative complications compared to those who maintained their regular diet.

Patients receiving nutritional support showed stable or improved laboratory parameters, while those in the control group experienced significant declines, highlighting the importance of preoperative nutrition even in nonmalnourished individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial. Kabata, P., Jastrzębski, T., Kąkol, M., et al.[2022]

Malnutrition is prevalent among surgical cancer patients and can negatively impact their recovery after surgery, making nutritional assessment crucial for optimizing treatment strategies.

Preoperative nutrition therapies are recommended for malnourished patients, with enteral nutrition generally offering a better risk-benefit ratio, and early oral nutrition post-surgery is advised for all patients undergoing major elective surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Artificial Nutrition on Postoperative Complications. Sandrucci, S., Cotogni, P., De Zolt Ponte, B.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Perioperative nutritional supplementation-what is really evidence based?] [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Perioperative nutritional therapy and its relevance for postoperative outcome]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery. [2021]

4. England pubmed.ncbi.nlm.nih.gov

ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of long-lasting nutritional prehabilitation on postoperative outcome in elective surgery for IBD. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Nutrition for the high-risk surgical patient, when they need it most: Question and answer session. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prehabilitation and Nutritional Support to Improve Perioperative Outcomes. [2023]

9. Egypt pubmed.ncbi.nlm.nih.gov

Perioperative nutrition in abdominal surgery: recommendations and reality. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Perioperative nutrition and enhanced recovery after surgery in gastrointestinal cancer patients. A position paper by the ESSO task force in collaboration with the ERAS society (ERAS coalition). [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Artificial Nutrition on Postoperative Complications. [2020]