Indian Researchers at Tata Memorial Centre Show Papaya Leaf Extract Improves Chemotherapy-Induced Thrombocytopenia in Phase III Trial

Researchers at Tata Memorial Centre (TMC), Mumbai, have reported encouraging Phase III evidence that Carica papaya leaf extract (CPLE) may address one of chemotherapy’s most common treatment-limiting complications. Conducted by the institute’s GI Medical Oncology team, the multicenter, triple-blinded, randomized, placebo-controlled PACT trial showed that CPLE accelerated platelet recovery in patients with chemotherapy-induced thrombocytopenia (CIT), reduced chemotherapy dose delays and reductions, and demonstrated a favorable safety profile compared with placebo.

The findings, published in JCO Global Oncology, highlight a potentially affordable supportive care strategy for maintaining chemotherapy intensity.

Chemotherapy-induced thrombocytopenia remains a common complication of cancer treatment. Low platelet counts increase bleeding risk and frequently force oncologists to delay chemotherapy or reduce treatment intensity, potentially compromising cancer outcomes. Current management options, including platelet transfusions and thrombopoietin receptor agonists, are effective but are often limited by cost, availability, and adverse effects. Carica papaya leaf extract has previously demonstrated platelet-raising activity in dengue-associated thrombocytopenia and smaller oncology studies, prompting evaluation in a large randomized clinical trial.

Phase III PACT Trial Demonstrated Faster Platelet Recovery

The investigator-initiated PACT trial enrolled 219 adults with solid tumors who developed platelet counts below 75,000/µL after chemotherapy across two cancer centers between March 2020 and October 2024. Participants were randomized in a 2:1 ratio to receive oral CPLE 1,100 mg three times daily or matching placebo for up to ten days or until platelet recovery. The primary endpoint evaluated the proportion of patients whose platelet count recovered to 75,000/µL or higher by Day 4 using a modified intention-to-treat analysis.

Among 198 patients included in the primary efficacy analysis, 59% of patients receiving CPLE achieved platelet recovery by Day 4 compared with 44% in the placebo group (P = .042). Per-protocol analysis showed similar findings, with recovery observed in 64% versus 48% of patients, respectively (P = .034). Kaplan-Meier analysis also demonstrated significantly faster platelet recovery with CPLE. By Day 10, most patients in both groups had recovered, although recovery occurred earlier in the treatment arm.

The treatment also produced meaningful clinical benefits beyond laboratory improvement. Among patients with baseline grade 2 thrombocytopenia, 25% of those receiving CPLE required chemotherapy dose reductions or treatment delays compared with 43% of patients receiving placebo. Benefits appeared particularly pronounced in patients aged 60 years or older, those receiving palliative chemotherapy, patients undergoing more than two chemotherapy cycles, and individuals treated every three weeks.

Favorable Safety Profile Supports Supportive Care Potential

Safety outcomes remained reassuring throughout the study. No grade 3 or grade 4 treatment-related adverse events occurred in the CPLE group, and only one patient in the placebo arm experienced clinically significant bleeding requiring platelet transfusion.

Exploratory biomarker analyses showed no significant upregulation of the ALOX12 gene, suggesting platelet recovery may occur through alternative pathways without evidence of increased thrombosis-related signaling.

Lead investigator Dr. Vikas Ostwal and colleagues concluded that CPLE may offer an inexpensive supportive care strategy for managing chemotherapy-induced thrombocytopenia, particularly in regions where access to thrombopoietin receptor agonists or repeated platelet transfusions is limited. The investigators noted that a standard 10-day treatment course costs approximately US$10, substantially less than existing pharmacologic alternatives.

Implications for Cancer Care

Although the trial establishes proof of clinical benefit, the investigators acknowledge that longer follow-up and additional multicenter studies are needed to confirm long-term safety, evaluate survival outcomes, and determine whether routine use of CPLE can consistently preserve chemotherapy dose intensity across broader cancer populations. If validated, the extract could become an accessible supportive therapy for chemotherapy-induced thrombocytopenia, particularly in resource-constrained healthcare settings.

What This Means for Patients

Patients receiving chemotherapy often experience low platelet counts, which can increase the risk of bleeding and force oncologists to delay treatment or reduce chemotherapy doses. Findings from this Phase III trial suggest that Carica papaya leaf extract may help platelets recover more quickly, allowing more patients to stay on their planned chemotherapy schedule. The findings may be particularly relevant in low- and middle-income settings, where access to costly platelet transfusions or thrombopoietin receptor agonists can be limited. As a relatively inexpensive intervention, CPLE could offer a more accessible supportive care option for eligible patients if its benefits are confirmed in broader clinical practice. However, it has not yet become a standard treatment for chemotherapy-induced thrombocytopenia, and patients should use it only under the guidance of their oncology team until additional studies and clinical recommendations become available.

Reference

Tata Memorial Centre Study validates Papaya Leaf Extract as a Low-Cost Solution for Chemotherapy-Related Low Platelet Counts

Vikas Ostwal et al., Carica Papaya Leaf Extract to Improve Chemotherapy-Induced Thrombocytopenia: A Phase III Triple-Blinded, Randomized, Placebo-Controlled, Multicentric Trial. JCO Glob Oncol 12, e2500386(2026). https://doi.org/10.1200/GO-25-00386