Exercise + Nicotinamide Riboside for Cancer Survivors with Insulin Resistance

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: NAD+ precursors, Diabetes meds

Disqualifiers: Pregnancy, Injury, Pacemaker, others

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

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise and a supplement called nicotinamide riboside, similar to vitamin B3, can benefit muscle health and insulin resistance in childhood cancer survivors with prediabetes. Prediabetes refers to a higher-than-normal blood sugar level, not yet high enough to be classified as diabetes. By studying these treatments, the trial aims to improve health outcomes for childhood cancer survivors. Participants should be cancer survivors in remission with prediabetes, who can access an online exercise program at home. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance long-term health for childhood cancer survivors.

Do I need to stop my current medications to join the trial?

If you are currently taking medication for high blood sugar or diabetes, you cannot join the trial. Otherwise, the trial does not specify if you need to stop other medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nicotinamide riboside is generally safe for people. Similar to vitamin B3, most individuals tolerate it well. Studies have found that it doesn't cause major side effects. Participants have taken up to 300 mg a day, experiencing only mild issues like an upset stomach or nausea.

Regular physical activity is often recommended to improve health. Exercise is usually safe and can enhance fitness and muscle strength. Overall, both nicotinamide riboside and exercise have been well-tolerated by participants in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of exercise and nicotinamide riboside for cancer survivors with insulin resistance because it offers a novel, two-pronged approach. While traditional treatments for insulin resistance often involve medications like metformin or lifestyle changes such as diet and exercise alone, this approach uniquely combines structured home exercise with nicotinamide riboside, a vitamin B3 derivative. Nicotinamide riboside is thought to enhance cellular energy and metabolism, potentially offering additional benefits to insulin sensitivity beyond exercise alone. This combination may provide a more comprehensive strategy for improving metabolic health in cancer survivors, which is why it’s generating interest in the research community.

What evidence suggests that this trial's treatments could be effective for improving muscle health and insulin resistance in cancer survivors?

Research has shown that nicotinamide riboside, a type of vitamin B3, might help lower inflammation and improve muscle health. It raises NAD+ levels in the blood, which are important for energy and cell repair. Some studies suggest it could also help with nerve damage, such as that often caused by chemotherapy. In this trial, one group of participants will receive nicotinamide riboside alongside a home exercise program. Regular exercise helps the body use insulin better, managing blood sugar levels more effectively. Another group will engage in regular home exercise sessions. Together, these treatments might aid cancer survivors by improving muscle health and controlling blood sugar. ^{4 5 6 7 8}

Who Is on the Research Team?

Rusha Bhandari

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Adult survivors of childhood cancer who are at least 18 years old, in remission for at least 6 months, and have prediabetes can join. They must be able to exercise at home using an online program, speak English, and sign a consent form. Those with pacemakers, recent NAD+ precursor use, diabetes medication use, MRI contraindications or current injuries cannot participate.

Inclusion Criteria

You can handle the specific exercise program given to you.

I can access an online exercise program from home.

It has been 6 months or more since I finished my cancer treatment.

Exclusion Criteria

You have a pacemaker.

You are unable to have a magnetic resonance imaging (MRI) scan for medical reasons.

I have taken a NAD+ precursor in the last two weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete home exercise sessions and may receive nicotinamide riboside for 6 weeks

6 weeks

18 home exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention
• Nicotinamide Riboside

Trial Overview The trial is testing the combination of exercise and a vitamin B3-like supplement called Nicotinamide Riboside on muscle health and insulin resistance in adults who survived childhood cancer but now face prediabetes. The goal is to find ways to improve their metabolic health.

How Is the Trial Designed?

Group I: Arm II (home exercise, nicotinamide riboside) Experimental Treatment 2 Interventions

Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.

Group II: Arm I (home exercise) Active Control 1 Intervention

Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7352172/

Nicotinamide Riboside—The Current State of Research and ... Furthermore, orally administered NR was found to improve resistance to and reversal of chemotherapeutic neuropathy [159]. This implies advantages of the NR ...

2. science.org science.org/doi/10.1126/sciadv.adi4862

What is really known about the effects of nicotinamide ... Nicotinamide riboside may play a role in the reduction of inflammatory states and has shown some potential in the treatment of diverse severe diseases.

3. nature.com nature.com/articles/s41598-024-66004-1

Novel insight into nicotinamide adenine dinucleotide and ... This study delves into NAD + dynamics in patients undergoing surgery for different digestive system cancers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10361580/

What is really known about the effects of nicotinamide ... Whole blood NAD+ levels were stably increased after 12 weeks of NR treatment, albeit with highly individual magnitude, and appeared to have ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2021-02807

Exercise and Nicotinamide Riboside for the Improvement ... This early phase I trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1560/nicotinamide-riboside

NICOTINAMIDE RIBOSIDE – Uses, Side Effects, and More When taken by mouth: Nicotinamide riboside chloride is possibly safe when used in doses up to 300 mg daily. Side effects are usually mild and might include ...

7. fda.gov fda.gov/files/food/published/GRAS-Notice-000635--Nicotinamide-riboside-chloride.pdf

GRAS Notice 635: Nicotinamide riboside chloride The intake of Niagen from the intended uses specified above has been shown to be safe and GRAS based on generally available and accepted ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611812/

Safety and Metabolism of Long-term Administration of ... NIAGEN is generally recognized as safe, with no significant adverse events reported. It does not elevate LDL cholesterol, and doses up to 1 ...