How high-intensity exercise and fibre affect immunotherapy outcomes for patients with melanoma

This trial will explore the effects of a high-fibre diet and high-intensity exercise on the gut microbiome, immune function and immunotherapy outcomes in melanoma patients.

  • Topic: Skin cancer
  • Institution: Dana-Farber Cancer Institute
  • Country: United States
  • Status: Ongoing
Researcher: Dong-Woo Kang

INSPIRE grant title: Modulating immune-microbiome axis through high-intensity exercise and high-fibre diet for immunotherapy outcomes in melanoma patients: the DUO trial

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I am thrilled that the DUO trial has been funded. This pilot randomised clinical trial will test the effects of a high-fibre diet and high-intensity exercise on the outcomes of immune-microbiome axis in melanoma patients receiving immunotherapy.

We will also examine how the gut microbiome mediates the immune response, which may ultimately impact the tolerance and efficacy of immunotherapy. We are grateful for World Cancer Research Fund’s generous support and hope the project will provide novel evidence on how diet and physical activity can impact cancer treatment and survivorship. – Dr Dong-Woo Kang


Melanoma is a type of skin cancer that can be aggressive and hard to treat. Immunotherapy has significantly increased the survival rate of patients with metastatic melanoma; however, half of these patients do not respond to current therapies and live less than 5 years after diagnosis. The reasons for this low response rate are not fully understood but may involve factors involving the immune system’s resistance to treatment.

The immune system can be modulated by the gut microbiome. Several studies have shown that the composition and diversity of the gut microbiome can affect the uptake or toxicity of immunotherapy, as well as the health-related outcomes and survival of cancer patients. Therefore, altering the gut microbiome through a high-fibre diet and high-intensity exercise intervention, both of which have been demonstrated to benefit the gut microbiome could improve immune function, and ultimately immunotherapy outcomes.


The researchers will run a randomised controlled trial to explore the effects of an 8-week high-fibre diet and high-intensity exercise intervention on the gut microbiome, immune function, and immunotherapy outcomes in melanoma patients undergoing immunotherapy. They will recruit 40 patients who will be randomised to either:

  1. high-fibre diet
  2. high-intensity exercise
  3. combined high-fibre diet and high-intensity exercise
  4. attention control

(ie 10 patients per group). The dietary intervention will incorporate remote-based dietary virtual consultations along with a dietary booklet, and the exercise intervention will be a 3-weekly virtually supervised exercise programme.


A high-fibre diet and high-intensity exercise combined will yield greater diversity in the gut microbiome measured as the Shannon Diversity Index, compared to high-intensity exercise only, high-fibre diet only, or attention control in melanoma patients undergoing immunotherapy.


This study will provide novel insights into the role of exercise and diet in regulating the immune system and enhancing the effect of immunotherapy in cancer treatment.

The results of the study will inform a larger clinical trial that will confirm the benefits of the combined exercise and diet programme in larger cohorts of melanoma patients undergoing immunotherapy.

Furthermore, the DUO Trial is expected to provide bold evidence on multiple research priorities by World Cancer Research Fund such as:

  1. directly targeting cancer treatment outcomes (ie immunotherapy) that potentially impact patients’ survivorship.
  2. testing a bold, unprecedented, yet evidence-based idea of using high-fibre diet and high-intensity exercise to address highly clinically relevant outcomes.
  3. incorporating microbiome as an important host factor and a critical contributor to immune function and potentially improve response to immunotherapy.