High Fiber Diet for Lung Cancer

Overseen By Wiam Belkaid, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must be taking: Immune checkpoint inhibitors

Disqualifiers: Severe dietary allergies, Psychiatric disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-center randomized trial in patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibition. Patients will receive standard-of-care immune checkpoint inhibitor (ICI) therapy alone or in combination with a dietary intervention.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 'High Fiber Diet for Lung Cancer'?

Research suggests that nutritional counseling and a diet rich in fiber and other nutrients can improve the quality of life and treatment response in lung cancer patients. Proper nutrition helps maintain body weight and energy levels, which are crucial during cancer treatment. ^{1 2 3 4 5}

Is a high fiber diet safe for humans?

A high fiber diet is generally safe for humans, with mild side effects like abdominal discomfort and gas. Some people may need to supplement with minerals like calcium and iron when increasing fiber intake. ^{6 7 8 9 10}

How does a high fiber diet differ from other treatments for lung cancer?

A high fiber diet is unique because it focuses on dietary changes rather than medication or surgery, potentially offering a non-invasive approach to support lung cancer treatment. While fiber is known for its benefits in reducing colon cancer risk, its role in lung cancer is less established, making this approach novel in exploring dietary impacts on lung cancer. ^{6 7 11 12 13}

Research Team

Bertrand Routy, MD,PhD

Principal Investigator

CHUM

Eligibility Criteria

This trial is for adults over 18 with confirmed non-small cell lung cancer (NSCLC) who are being treated with standard immune checkpoint inhibitors and can eat solid foods. It's not suitable for those with severe dietary allergies or psychiatric/substance abuse issues that could affect participation.

Inclusion Criteria

I am 18 years old or older.

Signed, informed consent

I have been diagnosed with non-small cell lung cancer and am treated with standard immune checkpoint inhibitors.

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

You have severe allergies to certain foods like shellfish, nuts, or seafood.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care immune checkpoint inhibitor (ICI) therapy alone or in combination with a dietary intervention

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Intervention

Trial Overview The study is testing if increasing total fiber intake affects the effectiveness of standard immune therapy in NSCLC patients. Participants will either continue their normal diet or follow a high-fiber diet alongside their regular cancer treatment.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients in the intervention arm will complete a dietary survey and be counselled on increasing their total fiber intake. Intervention group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.

Group II: Control Group Active Control 1 Intervention

Patients in the control arm will complete the dietary survey without dietary intervention or counselling from a dietician. Control group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

An anti-inflammatory diet that includes antioxidants, dietary fiber, and adequate protein can enhance treatment responses and improve the quality of life for lung cancer patients.

Proper nutritional therapy is crucial at all stages of lung cancer, as it can help prevent disease progression, support tissue regeneration after surgery, and improve overall nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Nutritional Support in Malnourished Patients With Lung Cancer. Kasprzyk, A., Bilmin, K., Chmielewska-Ignatowicz, T., et al.[2022]

Frequent nutritional counseling for cancer patients undergoing chemotherapy led to increased daily energy and protein intake, but did not result in significant changes in body weight or overall survival rates.

Despite improved dietary intake, there was no clinical benefit observed in terms of response rates or quality of life when comparing the counseling group to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. Ovesen, L., Allingstrup, L., Hannibal, J., et al.[2017]

Malnutrition affects 45% to 69% of lung cancer patients and is linked to worse clinical outcomes, highlighting the importance of nutritional support during treatment.

Dietary counseling during chemotherapy has been shown to improve energy and protein intake in lung cancer patients, but it does not appear to enhance other clinical outcomes; further research is needed to assess its impact during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of nutrition intervention in lung cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. Kiss, NK., Krishnasamy, M., Isenring, EA.[2018]

Nutritional interventions during chemotherapy for cancer patients can significantly improve quality of life, enhance treatment response, and potentially increase survival rates, highlighting the critical role of nutrition in cancer care.

Patients with lung cancer often face nutritional deficiencies that worsen their condition and treatment costs, indicating a need for further research on effective nutritional strategies to improve outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition screening and counseling in adults with lung cancer: a systematic review of the evidence. Moreland, SS.[2022]

Accelerated rehabilitation combined with enteral nutrition significantly improved nutritional markers (albumin, hemoglobin, and total lymphocyte counts) in lung cancer patients after surgery compared to conventional nutrition, indicating better recovery and immune function.

Patients in the enteral nutrition group experienced shorter hospitalization times and lower postoperative drainage volumes and expenses, highlighting the potential for this approach to enhance recovery and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated rehabilitation combined with enteral nutrition in the management of lung cancer surgery patients. Ding, Q., Chen, W., Gu, Y., et al.[2021]

A diet high in dietary fiber, particularly from wheat bran, is associated with a reduced risk of colon cancer, as shown in various studies including case-control and animal models.

Wheat bran specifically inhibits colon tumor development more effectively than other fiber sources like oat and corn bran, and it reduces levels of tumor promoters in the colon, highlighting its potential as a protective dietary component.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of dietary fiber in colon cancer: an overview. Reddy, BS.[2019]

Epidemiological studies suggest that increasing dietary fiber intake and reducing dietary fat may help lower the risk of developing colon cancer in humans.

Among various dietary fibers, wheat bran has shown the most promise in inhibiting colon tumor development, although animal studies have produced mixed results due to methodological differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and colon cancer: animal model studies. Reddy, BS.[2019]

Sodium butyrate, a metabolite of dietary fiber, effectively reduces colorectal cancer (CRC) burden by targeting the IL-6 receptor gp130 and inhibiting the IL-6/JAK2/STAT3 signaling pathway, as demonstrated through various in vitro and in vivo assays.

The study found that sodium butyrate decreases the levels of the gp130 protein by enhancing its degradation through TRAF5, suggesting a novel mechanism for its anticancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fiber metabolite butyrate reduces gp130 by targeting TRAF5 in colorectal cancer cells. Yuan, Y., Li, B., Kuang, Y., et al.[2022]

In a 12-week study with 28 volunteers, participants consumed a high-fiber snack providing 23 g of fiber and a low-fiber snack with 3.5 g, showing good compliance and minimal adverse effects like mild abdominal discomfort and gas.

The study indicated that while the high-fiber snack did not alter total energy intake or nutrient levels significantly, some participants experienced decreased serum ferritin and calcium, suggesting a need for mineral supplementation in high-fiber diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and cancer: a supplement for intervention studies. Bright-See, E., McKeown-Eyssen, G., Jacobson, EA., et al.[2017]

A review of 37 observational studies and meta-analyses of 16 case-control studies suggests that a high-fiber diet is associated with a reduced risk of colon cancer, with an estimated odds ratio of 0.57, indicating a significant protective effect.

While both fiber intake and vegetable consumption appear to lower colon cancer risk, the specific contributions of dietary fiber versus other beneficial components in vegetables remain unclear, as both factors are correlated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber, vegetables, and colon cancer: critical review and meta-analyses of the epidemiologic evidence. Trock, B., Lanza, E., Greenwald, P.[2022]

High fiber consumption is generally associated with lower colon cancer rates in humans, particularly from cereal fiber sources, although case-control studies do not consistently confirm a protective effect from dietary fiber alone.

Laboratory studies indicate that poorly fermentable fibers like wheat bran may protect against colon cancer, while some fermentable fibers can actually enhance tumor development, suggesting that the type of fiber and its properties play a crucial role in cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between dietary fiber and cancer: metabolic, physiologic, and cellular mechanisms. Jacobs, LR.[2020]

A large case-control study found that high dietary fiber intake is linked to a reduced risk of colorectal polyps, particularly among cigarette smokers, suggesting that fiber may play a protective role against colorectal cancer.

Cigarette smokers with a high fiber intake showed a 38% lower risk of developing high-risk adenomatous polyps compared to those with low fiber intake, highlighting the importance of dietary choices in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between dietary fiber and colorectal polyp risk differ by polyp type and smoking status. Fu, Z., Shrubsole, MJ., Smalley, WE., et al.[2023]

Inclusion of dietary fiber, specifically soft white wheat bran, significantly reduced the incidence and number of mammary carcinomas in female Sprague-Dawley rats during the promotion stage of carcinogenesis induced by DMBA.

A diet with 9.6% fiber not only decreased the development of mammary tumors in ovariectomized rats but also showed promising results in reducing tumor growth in virgin mice, indicating the potential of dietary fiber in cancer prevention across different animal models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of wheat bran fiber on the development of mammary tumors in female intact and ovariectomized rats treated with 7,12-dimethylbenz(a)anthracene and in mice with spontaneously developing mammary tumors. Zile, MH., Welsch, CW., Welsch, MA.[2019]

References

1. Greece pubmed.ncbi.nlm.nih.gov

The Role of Nutritional Support in Malnourished Patients With Lung Cancer. [2022]

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

Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. [2017]

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

The effect of nutrition intervention in lung cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. [2018]

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

Nutrition screening and counseling in adults with lung cancer: a systematic review of the evidence. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Accelerated rehabilitation combined with enteral nutrition in the management of lung cancer surgery patients. [2021]

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

Role of dietary fiber in colon cancer: an overview. [2019]

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

Dietary fiber and colon cancer: animal model studies. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The fiber metabolite butyrate reduces gp130 by targeting TRAF5 in colorectal cancer cells. [2022]

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

Dietary fiber and cancer: a supplement for intervention studies. [2017]

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

Dietary fiber, vegetables, and colon cancer: critical review and meta-analyses of the epidemiologic evidence. [2022]

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

Relationship between dietary fiber and cancer: metabolic, physiologic, and cellular mechanisms. [2020]

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

Associations between dietary fiber and colorectal polyp risk differ by polyp type and smoking status. [2023]

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

Effect of wheat bran fiber on the development of mammary tumors in female intact and ovariectomized rats treated with 7,12-dimethylbenz(a)anthracene and in mice with spontaneously developing mammary tumors. [2019]