Trial · NCT07897344
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
NCT07897344, Not applicable, Recruiting, Josephine Connolly-Schoonen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy. Trials, record NCT07897344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
- NCT number
- NCT07897344
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Josephine Connolly-Schoonen
- Conditions
- Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
- Interventions
- Dietary Protein Intervention
- First posted
- 2026-10-27
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of completing the intermittent, reduced protein diet intervention | Immediately after the intervention/pre-surgery | Percent of enrolled patients that complete the intervention (accept the interventional diet for 3 days before and day of chemotherapy and complete the diet intake surveys for at least 4 of the 5 diet periods) - Measured by uploaded/self-reported meal consumption pictures. |
| Primary | Recruitment of patients receiving neoadjuvant chemotherapy for breast cancer into an intermittent, reduced protein diet intervention | 18 months | Enrollment rate, defined as the percentage of patients offered participation who enroll in the study |
| Secondary | Adherence to the intermittent, reduced protein diet among patients receiving neoadjuvant chemotherapy for breast cancer | Up to 20 intervention days | Percent of patients who consume less or equal to 0.9 g of protein per kilogram of body weight over the intervention period - measured by uploaded/self-reported meal consumption pictures. |
| Secondary | Safety of an intermittent, reduced protein diet - weight change | Day of surgery/before surgery | Longitudinal weight change, measured by the InBody 380 device, in patients receiving neoadjuvant chemotherapy for breast cancer |
| Secondary | Safety of an intermittent, reduced protein diet - muscle mass change | Post-cycle 4 chemotherapy medical oncology visit (each cycle is 21 days) | Longitudinal muscle mass change, measured by the InBody 380 device, in patients receiving neoadjuvant chemotherapy for breast cancer |
| Secondary | Safety of an intermittent, reduced protein diet - fat mass change | Baseline, Cycle 4 Day 1 (each cycle is 21 days) and Preoperative evaluation (average of 6 months) | Longitudinal fat mass change, measured by the InBody 380 device, in patients receiving neoadjuvant chemotherapy for breast cancer |
| Secondary | Safety of an intermittent, reduced protein diet - handgrip strength change | Baseline, Cycle 4 Day 1 (each cycle is 21 days) and Preoperative evaluation (average of 6 months) | Longitudinal handgrip strength change, measured by the Jamar dynamometer, in patients receiving neoadjuvant chemotherapy for breast cancer |
| Secondary | Safety of an intermittent, reduced protein diet - frequency of post-operative complications | One month after primary breast surgery | Number of post-operative complications in breast cancer patients receiving neoadjuvant chemotherapy, assessed by chart review |
| Secondary | Safety of an intermittent, reduced protein diet - frequency of episodes of CTCAE greater than or equal to 3 non-hematologic toxicities | Chemotherapy Cycle 1 Day 1 to one day before surgery (each cycle is 21 days) | Number of episodes of CTCAE greater than or equal to 3 non-hematologic toxicity in patients receiving neoadjuvant chemotherapy for breast cancer, assessed by chart review |
| Secondary | Safety of an intermittent, reduced protein diet - frequency of patients who experience at least one CTCAE greater than or equal to 3 non-hematologic toxicities | Chemotherapy Cycle 1 Day 1 through chemotherapy Cycle 4 Day 0 (each cycle is 21 days) | Percent of patients who experience at least one CTCAE greater than or equal to 3 non-hematologic toxicity, assessed by chart review |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897344
GET https://conductscience.org/api/trials/v1/NCT07897344/registered