NCT03950635

Dietary Intervention in Patients with a History of Melanoma

Terminated Phase 1 Last updated 4 December 2024

What this trial tests

Phase 1 trial testing Dietary Intervention in Melanoma in 13 participants. Terminated before completion.

Timeline

16 April 2019

Primary endpoint
27 November 2024

27 November 2024

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	13
Start date	16 April 2019
Primary completion	27 November 2024
Estimated completion	27 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Dietary Intervention
• Dietary Intervention
• Questionnaire Administration

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research trial studies the effects of diet in patients with a history of melanoma. We are studying the impact of 2 different diets; a whole-foods, fiber-rich diet and a ketogenic diet. Participants will be assigned to one of these diets. During this study, participants will be provided all food at no cost for the entire 6-week study. Food can be picked up or shipped to the participant's home. However, participants will need to come into MD Anderson Cancer Center in Houston, TX, for the initial screening visit and for blood tests every 2 weeks during the study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The microbiome and human cancer.
   Sepich-Poore GD, Zitvogel L, Straussman R, Hasty J, et al · · 2021 · cited 945× · PMID 33766858 · DOI 10.1126/science.abc4552
2. Melanoma and microbiota: Current understanding and future directions.
   Routy B, Jackson T, Mählmann L, Baumgartner CK, et al · · 2024 · cited 66× · PMID 38157864 · DOI 10.1016/j.ccell.2023.12.003
3. Intratumor microbiome in cancer progression: current developments, challenges and future trends.
   Liu J, Zhang Y. · · 2022 · cited 52× · PMID 35642013 · DOI 10.1186/s40364-022-00381-5
4. Unveiling the intratumoral microbiota within cancer landscapes.
   Che S, Yan Z, Feng Y, Zhao H. · · 2024 · cited 28× · PMID 38799560 · DOI 10.1016/j.isci.2024.109893
5. Exploring the food-gut axis in immunotherapy response of cancer patients.
   Russo E, Nannini G, Dinu M, Pagliai G, et al · · 2020 · cited 22× · PMID 32952339 · DOI 10.3748/wjg.v26.i33.4919
6. Melanoma Cellular Signaling Transduction Pathways Targeted by Polyphenols Action Mechanisms.
   Isacescu E, Chiroi P, Zanoaga O, Nutu A, et al · · 2023 · cited 19× · PMID 36829966 · DOI 10.3390/antiox12020407
7. Gut microbiota and immunotherapy of renal cell carcinoma.
   Bibbò S, Porcari S, Del Vecchio LE, Severino A, et al · · 2023 · cited 11× · PMID 37955340 · DOI 10.1080/21645515.2023.2268982
8. Translating energy balance research from the bench to the clinic to the community: Parallel animal-human studies in cancer.
   Garcia MB, Schadler KL, Chandra J, Clinton SK, et al · · 2023 · cited 11× · PMID 36825928 · DOI 10.3322/caac.21773