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NCT04708860
Feasibility of Fasting & Exercise in Pts With HR+ MBC
NA trial testing Prolonged Nightly Fasting in Breast Cancer in 30 participants. Completed in 31 July 2024.
30 August 2022
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 30 |
| Start date | 15 January 2021 |
| Primary completion | 30 August 2022 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prolonged Nightly Fasting
- Exercise
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, female only, with Breast Cancer or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of fasting on cancer: A narrative review of scientific evidence.
Tiwari S, Sapkota N, Han Z. · · 2022 · cited 39× · PMID 35848874 · DOI 10.1111/cas.15492 -
Advances in Diet and Physical Activity in Breast Cancer Prevention and Treatment.
Khalifa A, Guijarro A, Nencioni A. · · 2024 · cited 17× · PMID 39064705 · DOI 10.3390/nu16142262 -
Neuroendocrine Tumors: A Comprehensive Review on Nutritional Approaches.
Muscogiuri G, Barrea L, Cantone MC, Guarnotta V, et al · · 2022 · cited 11× · PMID 36139562 · DOI 10.3390/cancers14184402 -
The Clinical Impact of Time-restricted Eating on Cancer: A Systematic Review.
Stringer EJ, Cloke RWG, Van der Meer L, Murphy RA, et al · · 2025 · cited 5× · PMID 39212676 · DOI 10.1093/nutrit/nuae105 -
Fasting and Exercise in Oncology: Potential Synergism of Combined Interventions.
Wilson RL, Kang DW, Christopher CN, Crane TE, et al · · 2021 · cited 5× · PMID 34684421 · DOI 10.3390/nu13103421
Verify or expand the search:
- PubMed search for NCT04708860
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Prolonged Nightly Fasting
Trials testing the same drug.
- NCT06938555 — The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors · NA · recruiting
- NCT05581849 — Prolonged Nightly Fasting in Fibromyalgia · NA · terminated
- NCT05083416 — Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome · NA · completed
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
- NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention · NA · not yet recruiting
- NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo · Phase 2 · not yet recruiting
- NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
- NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
- NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04708860 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
- Last refreshed: 16 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04708860.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing