Trial · NCT07897344
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | Safety of an intermittent, reduced protein diet - frequency of dose reduction or delay in chemotherapy | Chemotherapy Cycle 1 Day 1 through chemotherapy Cycle 4 Day 0 (each cycle is 21 days) | Number of episodes of dose reductions or delays in chemotherapy in patients receiving neoadjuvant treatment for breast cancer, assessed by chart review |
| Secondary | Tolerability of an intermittent, reduced protein diet - change in domain-specific self-reported gastrointestinal symptoms | Baseline, Cycle 1 Day 1 (each cycle is 21 days), Cycle 4 Day 1, and Preoperative evaluation (average of 6 months) | Change in self-reported Gastrointestinal symptoms measured by survey tool - (Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS-GI)). The PROMIS-GI is a standardized set of symptom scales. It evaluates 61 specific items across 8 domains: belly pain, bowel incontinence, constipation, diarrhea, disrupted swallowing, gas/bloating, gastroesophageal reflux, and nausea/vomiting. Scores are calibrated using standardized T-scores with a mean of 50 and a standard deviation of 10 in the U.S. general population. A higher score denotes more severe or frequent GI symptoms. |
| Secondary | Tolerability of an intermittent, reduced protein diet - change in self-reported total gastrointestinal symptoms | Baseline, Cycle 1 Day 1 (each cycle is 21 days), Cycle 4 Day 1, and Preoperative evaluation (average of 6 months) | Change in self-reported gastrointestinal symptom scores measured by survey tool - (Patient-Reported Outcomes Measurement Information System Gastrointestinal (PROMIS-GI)). The PROMIS-GI is a standardized set of symptom scales. It evaluates 61 specific items across 8 domains: belly pain, bowel incontinence, constipation, diarrhea, disrupted swallowing, gas/bloating, gastroesophageal reflux, and nausea/vomiting. Scores are calibrated using standardized T-scores with a mean of 50 and a standard deviation of 10 in the U.S. general population. A higher score denotes more severe or frequent GI symptoms. |
| Secondary | Tolerability of an intermittent, reduced protein diet - change in subjective global assessment score | Baseline, Cycle 1 Day 1 (each cycle is 21 days), Cycle 4 Day 1, and Preoperative evaluation (average of 6 months) | Change in subjective global assessment score measured by survey tool (Patient Generated Subjective Global Assessment (PG-SGA)). The PG-SGA is a 9-questions survey used to screen for malnutrition. It is a validated instrument that evaluates weight history, food intake, nutrition-related symptoms, functional status, disease-related metabolic stress, and physical findings to determine malnutrition risk and nutritional status. The PG-SGA total score ranges from 0 upward, with higher scores indicating greater nutritional risk and increased need for nutrition-related intervention. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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